Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin's Lymphoma (NHL)

• ClinicalTrials.gov Identifier: NCT01685008
• Recruitment Status: Completed
• First Posted: September 13, 2012
• Results First Posted: November 7, 2023
• Last Update Posted: November 7, 2023
• Sponsor: MorphoSys AG
• Information provided by (Responsible Party): MorphoSys AG

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-Hodgkin Lymphoma
• Intervention: Drug: MOR00208 (formerly Xmab 5574)
• Enrollment: 92

Participant Flow

Recruitment Details
Pre-assignment Details	All patients who fulfilled all the inclusion criteria and none of the exclusion criteria were enrolled and received MOR00208 infusion. Per planned analyses, patient disposition and treatment discontinuation is summarized by NHL subtype.

Arm/Group Title	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL
Arm/Group Description	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Period Title: Main Study Treatment (Cycles 1 - 2)
Started	34	35	12	11
Completed [1]	30	25	10	10
Not Completed	4	10	2	1
Reason Not Completed
Adverse Event	2	0	0	1
Physician Decision	0	2	0	0
Protocol Violation	0	1	0	0
Progressive Disease	2	4	1	0
Death	0	3	1	0
[1] Patients were considered to have completed the study if they finished the first 2 cycles of treatment plus the end of cycle 2 assessments.
Period Title: Cycle 3 and Maintenance Treatment
Started [1]	30	25	10	10
Began Cycle 3 Treatment	25	13	5	7
Entered Maintenance Phase Treatment	8	6	0	2
Completed	0	1	0	0
Not Completed	30	24	10	10
[1] Includes all patients that completed the first 2 cycles of treatment.

Baseline Characteristics

Arm/Group Title		FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	Total
Arm/Group Description		Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Total of all reporting groups
Overall Number of Baseline Participants		34	35	12	11	92
Baseline Analysis Population Description		Per planned analyses, baseline characteristics are summarized by NHL subtype.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	19 55.9%	16 45.7%	6 50.0%	2 18.2%	43 46.7%
	>=65 years	15 44.1%	19 54.3%	6 50.0%	9 81.8%	49 53.3%
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		62.88; (40 to 87)	66.71; (35 to 90)	64.92; (56 to 74)	70.91; (45 to 83)	65.57; (35 to 90)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
	Female	18 52.9%	11 31.4%	1 8.3%	6 54.5%	36 39.1%
	Male	16 47.1%	24 68.6%	11 91.7%	5 45.5%	56 60.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Asian	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		0 0.0%	1 2.9%	0 0.0%	0 0.0%	1 1.1%
Black or African American	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		0 0.0%	0 0.0%	1 8.3%	0 0.0%	1 1.1%
White	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		32 94.1%	33 94.3%	11 91.7%	11 100.0%	87 94.6%
Other	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		2 5.9%	1 2.9%	0 0.0%	0 0.0%	3 3.3%
Height [1]; Mean (Full Range); Unit of measure: Cm
	Number Analyzed	34 participants	33 participants	12 participants	11 participants	90 participants
		170.26; (150 to 244)	168.24; (150 to 184)	171.00; (150 to 191)	167.64; (160 to 178)	169.30; (150 to 244)
		[1] Measure Analysis Population Description: Height was not collected at Screening for 2 patients (minor protocol noncompliance)
Weight; Mean (Full Range); Unit of measure: Kg
	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		78.62; (51.0 to 123.6)	75.52; (46.0 to 122.5)	82.52; (63.9 to 131.0)	71.53; (50.0 to 92.0)	77.10; (46.0 to 131.0)
BMI [1]; Mean (Full Range); Unit of measure: Kg/m^2
	Number Analyzed	34 participants	33 participants	12 participants	11 participants	90 participants
		27.26; (12.6 to 39.3)	26.52; (18.9 to 41.1)	28.03; (22.1 to 36.1)	25.36; (18.4 to 32.0)	26.86; (12.6 to 41.1)
		[1] Measure Analysis Population Description: Height was not collected at Screening for 2 patients (minor protocol noncompliance)
NHL Subtype; Measure Type: Count of Participants; Unit of measure: Participants
Follicular lymphoma	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		34 100.0%	0 0.0%	0 0.0%	0 0.0%	34 37.0%
Diffuse large B-cell lymphoma	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		0 0.0%	35 100.0%	0 0.0%	0 0.0%	35 38.0%
Mantle cell lymphoma	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		0 0.0%	0 0.0%	12 100.0%	0 0.0%	12 13.0%
Other indolent NHL	Number Analyzed	34 participants	35 participants	12 participants	11 participants	92 participants
		0 0.0%	0 0.0%	0 0.0%	11 100.0%	11 12.0%

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR)
Description	Proportion of patients with Complete Remission (CR; disappearance of all evidence of disease) or Partial Remission (PR; regression of measurable disease and no new sites), assessed as per the 2007 International Working Group (IWG) response criteria by radiographic evaluations (CT, PET, MRI, or other).
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

The Intent-to-treat (ITT) Population consisted of all patients who received at least one dose of study drug. Patients without any post-Baseline assessment of NHL response were included as non-responders. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	92	34	35	12	11	45
Measure Type: Count of Participants; Unit of Measure: Participants
Complete remission	6 6.5%	2 5.9%	2 5.7%	0 0.0%	2 18.2%	4 8.9%
Partial remission	16 17.4%	8 23.5%	7 20.0%	0 0.0%	1 9.1%	9 20.0%

2. Secondary Outcome

Title	Stable Disease (SD) Rate
Description	Proportion of patients with Stable Disease (failure to attain CR/PR with no progressive disease)
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

The ITT Population consisted of all patients who received at least one dose of study drug. Patients without any post-Baseline assessment of NHL response were included as non-responders. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	92	34	35	12	11	45
Measure Type: Count of Participants; Unit of Measure: Participants
	31 33.7%	16 47.1%	5 14.3%	6 50.0%	4 36.4%	20 44.4%

3. Secondary Outcome

Title	Duration of Response (DoR)
Description	Time from first CR or PR to first documentation of relapse/progression (any new lesion or increase by ≥ 50% of previously identified site)
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

Patients in the ITT Population who had any response (CR or PR) during the study. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	22	10	9	0	3	13
Median (95% Confidence Interval); Unit of Measure: months
	24.0 [1]; (11.1 to NA)	24.0 [1]; (2.6 to NA)	20.1 [1]; (1.1 to NA)		NA [2]; (NA to NA)	NA [1]; (3.6 to NA)

[1]

Patients who showed a response during the study but did not have documented progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).

[2]

No responders had documented progression, therefore all patients in this population were censored and no median or confidence intervals were applicable.

4. Secondary Outcome

Title	Time to Progression (TTP)
Description	Time from first dosing until documentation of progression or death due to lymphoma
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

Patients in the ITT Population with documented progression of disease. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	76	31	25	11	9	40
Median (95% Confidence Interval); Unit of Measure: months
	5.4; (3.4 to 12.0)	8.8; (5.4 to 20.5)	3.1; (2.1 to 15.4)	3.0 [1]; (1.8 to NA)	NA [1]; (2.0 to NA)	6.6; (5.3 to 20.5)

[1]

Patients who did not have documented radiological progression (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).

5. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	Time from first dosing until progression or death due to any case
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

Patients in the ITT Population with documented progression of disease or death from any cause. Per pre-specified analysis plan, efficacy analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	80	31	28	12	9	40
Median (95% Confidence Interval); Unit of Measure: months
	5.4; (3.2 to 9.9)	8.8; (5.4 to 20.5)	2.7; (2.1 to 13.2)	2.1 [1]; (1.7 to NA)	NA [1]; (2.0 to NA)	6.6; (5.3 to 20.5)

[1]

Patients who did not have documented radiological progression, or death occurred beyond a pre-specified time frame (as described in the pre-specified analysis plan) were considered censored. Due to this statistical data censoring, there was an insufficient number of patients with events in the analysis population to compute median and/or confidence interval(s).

6. Secondary Outcome

Title	Incidence and Severity of Adverse Events (AEs)
Description	Number of patients with treatment-emergent AEs rated Mild, Moderate, and Severe
Time Frame	From first dose until 30 days after last dose of MOR00208, up to 8.5 years

Outcome Measure Data

Analysis Population Description

The Safety Population consisted of all patients who received at least one dose of study drug. Per pre-specified analysis plan, adverse event analyses are summarized overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	92	34	35	12	11	45
Measure Type: Count of Participants; Unit of Measure: Participants
Mild	29 31.5%	10 29.4%	12 34.3%	1 8.3%	6 54.5%	16 35.6%
Moderate	20 21.7%	8 23.5%	8 22.9%	2 16.7%	2 18.2%	10 22.2%
Severe	6 6.5%	2 5.9%	4 11.4%	0 0.0%	0 0.0%	2 4.4%

7. Secondary Outcome

Title	Number and Proportion of Patients Who Potentially Developed Anti-MOR00208 Antibodies and Semiquantitative Anti-MOR00208 Antibody Assessments
Description	Number of patients with at least one positive (+ve) post-Baseline sample containing positive anti-MOR00208 antibodies; Baseline (pre-dose) sample has to be tested negative (-ve)
Time Frame	From first dose until Follow-up Visit 3, up to 7 months

Outcome Measure Data

Analysis Population Description

The Safety Population (all patients who received at least one dose of study drug). Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	92	34	35	12	11	45
Measure Type: Count of Participants; Unit of Measure: Participants
Yes (at least 1 +ve post-Baseline sample, including +ve last sample; Baseline must be -ve)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
No (Baseline and all post-Baseline samples are -ve)	82 89.1%	31 91.2%	31 88.6%	10 83.3%	10 90.9%	41 91.1%
Transient (at least 1 +ve post-Baseline sample but -ve last sample; Baseline must be -ve)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Not evaluable (pre-dose Baseline sample tested +ve)	5 5.4%	3 8.8%	1 2.9%	1 8.3%	0 0.0%	3 6.7%
Missing (no post-Baseline measurement available)	5 5.4%	0 0.0%	3 8.6%	1 8.3%	1 9.1%	1 2.2%

8. Secondary Outcome

Title	Pharmacokinetic (PK) Parameter: Maximum Serum Concentration Observed (Cmax) of MOR00208
Description	The highest concentration of MOR00208 measured in serum
Time Frame	Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	85	33	32	11	9	42
Mean (Standard Deviation); Unit of Measure: μg/mL
	263.1 (111.35)	276.6 (73.10)	253.4 (157.79)	260.0 (69.85)	251.5 (70.31)	271.2 (72.42)

9. Secondary Outcome

Title	PK Parameter: Time to Maximum Serum Concentration Observed (Tmax) of MOR00208
Description	The time to highest concentration of MOR00208 measured in serum
Time Frame	Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	85	33	32	11	9	42
Mean (Standard Deviation); Unit of Measure: hours
	5.8 (17.46)	4.7 (5.27)	8.5 (27.99)	3.0 (1.03)	3.4 (1.38)	4.4 (4.72)

10. Secondary Outcome

Title	PK Parameter: Apparent Trough Serum Concentration Before Dosing (Clast) of MOR00208
Description	The last quantifiable concentration from the first dose of MOR00208
Time Frame	Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	85	33	32	11	9	42
Mean (Standard Deviation); Unit of Measure: μg/mL
	81.0 (36.66)	88.6 (39.50)	69.6 (28.96)	82.4 (34.54)	92.2 (47.23)	89.3 (40.69)

11. Secondary Outcome

Title	PK Parameter: Area Under the Concentration Curve From Dose Time Zero to the Time the Last Quantifiable Concentration is Observed (AUC[0-t]) of MOR00208
Description	Area under the concentration curve. The time curve from time zero (0) to the time that the last concentration above the lower limit of quantification (LLQ) is observed.
Time Frame	Estimated from first dose (samples taken on first day of dosing at pre-dose, end of infusion, after 1 hour, 4 hours, 24 hours, and pre-dose on Day 8)

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	85	33	32	11	9	42
Mean (Standard Deviation); Unit of Measure: h*μg/mL
	21942.5 (11847.35)	25088.6 (16245.82)	19106.3 (8170.03)	21617.1 (4577.21)	20888.5 (7669.67)	24188.6 (14849.65)

12. Secondary Outcome

Title	PK Parameter: Area Under the Concentration Curve From Dose Time Zero to Infinity (AUC[0-inf]) of MOR00208
Description	Area under the concentration curve. The time curve from time zero (0) to infinity (inf), where infinity is computed from AUC0-t + [Ct/λZ)]. Ct is calculated from the concentration at the last sampling time at which the sample is above LLQ.
Time Frame	Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	91	33	35	12	11	44
Mean (Standard Deviation); Unit of Measure: h*μg/mL
	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)

[1]

There were not sufficient data available to allow parameter estimation.

13. Secondary Outcome

Title	PK Parameter: Apparent Terminal Rate Constant (λz) of MOR00208
Description	Apparent terminal rate constant calculated from the regression analysis (slope) from the log-transformed measured concentrations on the terminal phase of the time-point concentration curve
Time Frame	Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	12	9	0	2	1	10
Mean (Standard Deviation); Unit of Measure: 1/h
	0.00214 (0.000665)	0.00214 (0.000707)		0.00207 (0.000896)	0.00234 [1] (NA)	0.00216 (0.000670)

[1]

Standard deviation is not applicable for a sample size of 1.

14. Secondary Outcome

Title	PK Parameter: Apparent Terminal Half-life (t[1/2]) of MOR00208
Description	Apparent terminal half-life calculated from ln(2)/λz
Time Frame	Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	12	9	0	2	1	10
Mean (Standard Deviation); Unit of Measure: days
	14.75111 (4.680075)	14.87185 (4.863339)		15.42457 (6.690102)	12.31761 [1] (NA)	14.61642 (4.655799)

[1]

Standard deviation is not applicable for a sample size of 1.

15. Secondary Outcome

Title	PK Parameter: Total Body Clearance (CL) of MOR00208
Description	Total body clearance calculated for single or multiple doses: dose(s)/AUC(0-inf)
Time Frame	Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	91	33	35	12	11	44
Mean (Standard Deviation); Unit of Measure: L/h
	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)

[1]

There were not sufficient data available to allow parameter estimation.

16. Secondary Outcome

Title	PK Parameter: Apparent Volume of Distribution (Vz) of MOR00208
Description	Apparent volume of distribution during the terminal phase, calculated from dose/(AUC(0-inf)*λz)
Time Frame	Estimated from final dose (samples collected on the last day of Cycle 3 [C3D28; each cycle is 28 days long], and Follow-up Visits 1 [C3D28 + 4 weeks], 2 [C3D28 + 10 weeks], and 3 [C3D28 + 16 weeks])

Outcome Measure Data

Analysis Population Description

The PK Population included all patients who had at least one quantifiable serum MOR00208 concentration. PK parameters were calculated as data permitted. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	91	33	35	12	11	44
Mean (Standard Deviation); Unit of Measure: L
	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)	NA [1] (NA)

[1]

There were not sufficient data available to allow parameter estimation.

17. Secondary Outcome

Title	Absolute Change From Baseline in Measurements of B-cell Populations
Description	Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Time Frame	Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

Outcome Measure Data

Analysis Population Description

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		70	26	31	8	5	31
Median (95% Confidence Interval); Unit of Measure: 10^6 cells/L
Cycle 1 Day 8	Number Analyzed	65 participants	24 participants	28 participants	8 participants	5 participants	29 participants
		-13.60; (-50.250 to -1.000)	-68.00; (-141.000 to -1.000)	0.00; (-13.600 to 10.000)	-61.13; (-214.200 to 7618.000)	-65.00; (-108.000 to 13.000)	-65.00; (-108.000 to -2.000)
Cycle 1 Day 15	Number Analyzed	65 participants	26 participants	27 participants	7 participants	5 participants	31 participants
		-15.00; (-55.940 to -3.000)	-60.50; (-171.000 to -10.000)	-3.00; (-15.000 to 6.000)	-47.00; (-687.000 to 26570.000)	-47.00; (-110.000 to 0.000)	-57.00; (-110.020 to -10.000)
Cycle 1 Day 22	Number Analyzed	61 participants	23 participants	26 participants	7 participants	5 participants	28 participants
		-14.00; (-57.000 to -4.500)	-34.00; (-148.000 to -6.000)	-4.25; (-19.000 to 0.000)	-65.01; (-680.000 to 1487.000)	-60.00; (-120.000 to 33.000)	-44.00; (-105.980 to -6.000)
Cycle 2 Day 1	Number Analyzed	58 participants	24 participants	24 participants	5 participants	5 participants	29 participants
		-14.00; (-51.710 to -3.600)	-45.00; (-141.000 to -2.000)	-4.00; (-17.000 to 1.000)	-51.71; (-697.000 to 2025.000)	-3.00; (-121.000 to 42.000)	-34.00; (-116.390 to -2.000)
Cycle 2 Day 15	Number Analyzed	54 participants	20 participants	22 participants	7 participants	5 participants	25 participants
		-24.00; (-61.000 to -12.000)	-47.50; (-181.210 to 0.000)	-14.25; (-23.000 to -4.900)	-61.45; (-673.000 to 9637.000)	-56.00; (-120.000 to 20.000)	-56.00; (-120.000 to -5.500)
Cycle 2 Day 28	Number Analyzed	48 participants	21 participants	18 participants	5 participants	4 participants	25 participants
		-27.68; (-59.000 to -8.000)	-28.00; (-115.120 to -0.800)	-14.50; (-35.000 to -1.970)	-176.85; (-661.000 to -28.000)	-38.00; (-120.000 to -4.000)	-28.00; (-94.000 to -3.880)
Cycle 3 Day 1	Number Analyzed	33 participants	17 participants	9 participants	3 participants	4 participants	21 participants
		-36.00; (-117.990 to 0.000)	-43.00; (-171.000 to 5.000)	-16.00; (-238.000 to 0.000)	-13.06; (-718.000 to 2.000)	-68.00; (-129.000 to 16.000)	-64.00; (-129.000 to 5.000)
Cycle 3 Day 15	Number Analyzed	30 participants	16 participants	8 participants	3 participants	3 participants	19 participants
		-36.50; (-135.720 to 0.000)	-33.50; (-171.000 to 10.000)	-22.00; (-241.000 to 21.000)	-256.72; (-615.000 to -30.000)	-77.00; (-127.000 to -6.000)	-35.00; (-127.000 to 9.000)
Cycle 3 Day 28	Number Analyzed	33 participants	18 participants	8 participants	3 participants	4 participants	22 participants
		-46.00; (-94.000 to -8.370)	-60.50; (-171.000 to 10.000)	-16.50; (-124.800 to 35.000)	-43.00; (-689.000 to 76.530)	-59.00; (-129.000 to -5.000)	-60.50; (-121.180 to -5.000)
Study Completion/Early Termination	Number Analyzed	43 participants	17 participants	17 participants	5 participants	4 participants	21 participants
		-15.00; (-69.820 to 4.000)	-72.00; (-241.000 to 8.000)	-1.67; (-22.100 to 7.000)	-49.00; (-618.000 to 63413.000)	-40.50; (-133.000 to 22.000)	-72.00; (-240.000 to 8.000)

18. Secondary Outcome

Title	Percent Change From Baseline in Measurements of B-cell Populations
Description	Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: B-cell populations
Time Frame	Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

Outcome Measure Data

Analysis Population Description

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		70	26	31	8	5	31
Median (95% Confidence Interval); Unit of Measure: percentage change from baseline
Cycle 1 Day 8	Number Analyzed	60 participants	22 participants	25 participants	8 participants	5 participants	27 participants
		-42.07; (-70.588 to -2.793)	-80.64; (-95.914 to -25.000)	-0.64; (-49.333 to 72.857)	-40.32; (-77.154 to 1451.048)	-74.47; (-81.203 to 118.182)	-76.47; (-85.116 to -25.000)
Cycle 1 Day 15	Number Analyzed	61 participants	24 participants	25 participants	7 participants	5 participants	29 participants
		-50.00; (-79.422 to -32.353)	-87.11; (-95.947 to -46.341)	-32.35; (-67.442 to 11.429)	-40.17; (-85.160 to 5060.952)	-50.00; (-87.059 to 0.000)	-82.71; (-94.253 to -46.341)
Cycle 1 Day 22	Number Analyzed	57 participants	21 participants	24 participants	7 participants	5 participants	26 participants
		-55.88; (-82.625 to -27.500)	-83.23; (-100.000 to -35.800)	-35.77; (-67.857 to -5.714)	-82.62; (-90.556 to 33.514)	-63.83; (-90.226 to 71.739)	-68.39; (-96.279 to -35.800)
Cycle 2 Day 1	Number Analyzed	54 participants	22 participants	22 participants	5 participants	5 participants	27 participants
		-55.63; (-80.000 to -27.273)	-82.65; (-94.312 to -25.102)	-40.18; (-61.905 to 27.778)	-72.03; (-85.171 to 45.639)	-27.27; (-90.977 to 54.348)	-80.18; (-92.093 to -25.102)
Cycle 2 Day 15	Number Analyzed	50 participants	18 participants	20 participants	7 participants	5 participants	23 participants
		-73.80; (-83.542 to -57.407)	-81.98; (-100.000 to -35.667)	-67.32; (-83.542 to -31.250)	-74.07; (-93.373 to 217.196)	-71.76; (-100.000 to 43.478)	-78.05; (-97.957 to -57.407)
Cycle 2 Day 28	Number Analyzed	45 participants	20 participants	16 participants	5 participants	4 participants	24 participants
		-76.47; (-86.458 to -38.095)	-87.25; (-100.000 to -7.143)	-59.07; (-83.415 to -23.529)	-71.67; (-96.062 to -30.769)	-52.89; (-90.226 to -18.085)	-82.87; (-94.419 to -18.085)
Cycle 3 Day 1	Number Analyzed	29 participants	15 participants	7 participants	3 participants	4 participants	19 participants
		-79.63; (-94.585 to -3.666)	-93.06; (-96.639 to 22.997)	-82.64; (-98.333 to 142.105)	-3.67; (-87.242 to 3.704)	-76.06; (-96.992 to 145.455)	-79.63; (-95.608 to 22.997)
Cycle 3 Day 15	Number Analyzed	27 participants	14 participants	7 participants	3 participants	3 participants	17 participants
		-72.07; (-93.953 to -33.333)	-76.61; (-96.479 to 48.780)	-45.24; (-94.792 to 110.526)	-72.07; (-74.727 to -55.556)	-90.59; (-95.489 to -54.545)	-90.59; (-96.390 to 0.000)
Cycle 3 Day 28	Number Analyzed	29 participants	16 participants	6 participants	3 participants	4 participants	20 participants
		-80.00; (-95.833 to -53.191)	-96.06; (-98.193 to -37.085)	-66.27; (-87.847 to 184.211)	-79.63; (-83.718 to 21.484)	-66.60; (-96.992 to -45.455)	-90.45; (-97.611 to -53.191)
Study Completion/Early Termination	Number Analyzed	41 participants	15 participants	17 participants	5 participants	4 participants	19 participants
		-49.31; (-85.444 to 2.941)	-87.00; (-95.725 to -14.925)	-45.44; (-52.500 to 37.500)	-75.09; (-93.911 to 1429.186)	-40.86; (-100.000 to 200.000)	-87.00; (-95.122 to 8.696)

19. Secondary Outcome

Title	Absolute Change From Baseline in Measurements of T-cell Populations
Description	Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Time Frame	Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

Outcome Measure Data

Analysis Population Description

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		71	26	30	9	6	32
Median (95% Confidence Interval); Unit of Measure: 10^6 cells/L
Cycle 1 Day 8	Number Analyzed	64 participants	24 participants	27 participants	8 participants	5 participants	29 participants
		41.00; (-3.460 to 89.000)	12.38; (-103.000 to 162.000)	89.00; (46.000 to 260.000)	-55.92; (-219.000 to 600.000)	16.00; (-1119.000 to 269.000)	16.00; (-98.000 to 85.000)
Cycle 1 Day 15	Number Analyzed	65 participants	26 participants	27 participants	7 participants	5 participants	31 participants
		12.00; (-67.000 to 80.000)	3.00; (-301.000 to 123.000)	28.00; (-43.000 to 196.000)	-22.00; (-193.000 to 1042.000)	-94.00; (-1011.000 to 526.000)	-19.00; (-297.790 to 110.000)
Cycle 1 Day 22	Number Analyzed	61 participants	23 participants	26 participants	7 participants	5 participants	28 participants
		-10.00; (-70.880 to 34.000)	-31.00; (-180.000 to 34.000)	26.00; (-114.000 to 184.000)	-3.00; (-452.000 to 1129.500)	-41.00; (-252.000 to 71.000)	-36.00; (-180.000 to 26.000)
Cycle 2 Day 1	Number Analyzed	58 participants	24 participants	24 participants	5 participants	5 participants	29 participants
		17.50; (-100.000 to 61.000)	-26.00; (-190.000 to 152.000)	42.50; (-105.000 to 94.000)	-96.00; (-531.110 to 127.610)	-40.00; (-537.000 to 844.000)	-40.00; (-137.000 to 111.000)
Cycle 2 Day 15	Number Analyzed	53 participants	20 participants	22 participants	7 participants	4 participants	24 participants
		88.00; (-9.000 to 152.000)	59.98; (-117.000 to 153.000)	72.00; (-115.000 to 184.000)	164.00; (-9.000 to 719.030)	54.50; (-28.000 to 422.000)	59.98; (-72.000 to 153.000)
Cycle 2 Day 28	Number Analyzed	48 participants	21 participants	18 participants	5 participants	4 participants	25 participants
		99.00; (-17.000 to 250.000)	32.87; (-120.800 to 286.000)	176.64; (-142.000 to 386.000)	133.00; (39.320 to 1051.410)	108.00; (-103.000 to 365.000)	38.00; (-69.000 to 259.000)
Cycle 3 Day 1	Number Analyzed	33 participants	17 participants	9 participants	3 participants	4 participants	21 participants
		58.00; (-69.000 to 158.500)	45.00; (-140.000 to 267.000)	115.00; (-100.000 to 222.700)	174.00; (96.000 to 889.090)	-32.00; (-203.000 to 90.000)	-4.00; (-140.000 to 158.500)
Cycle 3 Day 15	Number Analyzed	30 participants	16 participants	8 participants	3 participants	3 participants	19 participants
		110.00; (-27.000 to 318.000)	94.00; (-111.930 to 383.000)	203.50; (-517.000 to 462.000)	599.00; (143.000 to 770.010)	-27.00; (-212.000 to 112.000)	80.00; (-111.930 to 213.000)
Cycle 3 Day 28	Number Analyzed	33 participants	18 participants	8 participants	3 participants	4 participants	22 participants
		102.45; (-40.000 to 243.000)	72.23; (-110.000 to 448.000)	198.31; (-403.000 to 696.000)	131.00; (-131.000 to 1279.070)	72.50; (-78.000 to 366.000)	72.50; (-40.000 to 366.000)
Study Completion/Early Termination	Number Analyzed	44 participants	17 participants	18 participants	5 participants	4 participants	21 participants
		-57.50; (-137.000 to 144.000)	-104.00; (-224.000 to 228.470)	-84.00; (-305.000 to 139.000)	165.00; (-174.000 to 361.170)	361.50; (-1079.000 to 2592.000)	-55.00; (-224.000 to 411.000)

20. Secondary Outcome

Title	Percent Change From Baseline in Measurements of T-cell Populations
Description	Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: T-cell populations
Time Frame	Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

Outcome Measure Data

Analysis Population Description

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		71	26	30	9	6	32
Median (95% Confidence Interval); Unit of Measure: percentage change from baseline
Cycle 1 Day 8	Number Analyzed	64 participants	24 participants	27 participants	8 participants	5 participants	29 participants
		7.28; (-0.394 to 16.991)	1.59; (-8.906 to 18.456)	17.07; (10.242 to 37.132)	-7.26; (-35.371 to 83.565)	5.11; (-47.800 to 16.205)	1.60; (-8.906 to 15.018)
Cycle 1 Day 15	Number Analyzed	65 participants	26 participants	27 participants	7 participants	5 participants	31 participants
		1.75; (-9.999 to 12.312)	1.25; (-17.200 to 14.604)	8.81; (-15.314 to 44.118)	-4.01; (-26.187 to 145.125)	-17.49; (-43.187 to 31.687)	-1.99; (-17.491 to 12.312)
Cycle 1 Day 22	Number Analyzed	61 participants	23 participants	26 participants	7 participants	5 participants	28 participants
		-1.63; (-10.213 to 6.436)	-1.83; (-13.413 to 6.436)	5.62; (-20.394 to 39.280)	-0.41; (-82.332 to 168.088)	-10.76; (-38.693 to 22.684)	-3.17; (-13.012 to 4.361)
Cycle 2 Day 1	Number Analyzed	58 participants	24 participants	24 participants	5 participants	5 participants	29 participants
		2.93; (-12.484 to 12.025)	-1.63; (-17.286 to 14.765)	10.38; (-7.023 to 20.524)	-12.48; (-76.529 to 14.538)	-12.78; (-38.701 to 50.843)	-2.36; (-17.286 to 14.765)
Cycle 2 Day 15	Number Analyzed	53 participants	20 participants	22 participants	7 participants	4 participants	24 participants
		10.39; (-1.170 to 22.944)	7.34; (-11.716 to 23.043)	15.35; (-11.358 to 38.971)	12.25; (-1.170 to 107.003)	3.46; (-7.910 to 18.026)	6.82; (-7.910 to 22.944)
Cycle 2 Day 28	Number Analyzed	48 participants	21 participants	18 participants	5 participants	4 participants	25 participants
		9.91; (-3.321 to 30.339)	5.96; (-8.938 to 29.916)	36.51; (-10.132 to 73.662)	20.58; (5.666 to 156.467)	17.52; (-29.096 to 64.488)	7.64; (-7.240 to 27.157)
Cycle 3 Day 1	Number Analyzed	33 participants	17 participants	9 participants	3 participants	4 participants	21 participants
		12.99; (-6.114 to 23.810)	9.60; (-9.799 to 27.929)	18.67; (-7.159 to 43.226)	17.49; (12.995 to 132.311)	-2.37; (-35.866 to 28.754)	-1.13; (-9.799 to 27.929)
Cycle 3 Day 15	Number Analyzed	30 participants	16 participants	8 participants	3 participants	3 participants	19 participants
		20.09; (-7.627 to 34.934)	9.57; (-12.210 to 34.934)	20.66; (-14.130 to 100.873)	44.73; (26.047 to 114.590)	-7.63; (-37.456 to 35.783)	6.38; (-12.210 to 34.934)
Cycle 3 Day 28	Number Analyzed	33 participants	18 participants	8 participants	3 participants	4 participants	22 participants
		17.34; (-9.783 to 26.905)	11.37; (-13.423 to 33.794)	21.90; (-18.260 to 151.965)	23.86; (-9.783 to 190.346)	17.10; (-13.781 to 32.588)	14.15; (-11.156 to 32.588)
Study Completion/Early Termination	Number Analyzed	44 participants	17 participants	18 participants	5 participants	4 participants	21 participants
		-8.07; (-14.994 to 26.912)	-12.80; (-18.456 to 29.129)	-8.07; (-42.093 to 32.548)	12.32; (-31.694 to 52.042)	28.31; (-65.000 to 457.951)	-12.21; (-18.456 to 29.712)

21. Secondary Outcome

Title	Absolute Change From Baseline in Measurements of NK Cell Populations
Description	Actual change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Time Frame	Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

Outcome Measure Data

Analysis Population Description

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		71	26	30	9	6	32
Median (95% Confidence Interval); Unit of Measure: 10^6 cells/L
Cycle 1 Day 8	Number Analyzed	64 participants	24 participants	27 participants	8 participants	5 participants	29 participants
		-2.20; (-21.000 to 15.000)	-20.00; (-38.000 to 15.000)	20.00; (-10.000 to 41.000)	-59.50; (-113.860 to 6.570)	8.00; (-300.000 to 70.000)	-20.00; (-38.000 to 15.000)
Cycle 1 Day 15	Number Analyzed	65 participants	26 participants	27 participants	7 participants	5 participants	31 participants
		-23.00; (-43.000 to 11.000)	-36.99; (-67.000 to 28.090)	-4.00; (-26.250 to 23.000)	-33.00; (-216.000 to 117.000)	-79.00; (-211.000 to 66.000)	-38.97; (-73.000 to 20.000)
Cycle 1 Day 22	Number Analyzed	61 participants	23 participants	26 participants	7 participants	5 participants	28 participants
		-18.00; (-38.000 to 7.550)	-28.00; (-48.000 to 7.550)	27.06; (-24.000 to 71.000)	-133.68; (-248.000 to -6.440)	-60.00; (-345.000 to 42.000)	-30.00; (-60.000 to 6.000)
Cycle 2 Day 1	Number Analyzed	58 participants	24 participants	24 participants	5 participants	5 participants	29 participants
		-16.32; (-33.000 to 9.890)	-11.01; (-39.730 to 21.000)	-21.31; (-37.000 to 19.000)	-64.00; (-249.000 to 556.030)	-1.00; (-146.000 to 135.000)	-7.00; (-31.000 to 21.000)
Cycle 2 Day 15	Number Analyzed	53 participants	20 participants	22 participants	7 participants	4 participants	24 participants
		-19.00; (-32.000 to 16.800)	6.00; (-29.000 to 35.000)	-14.00; (-47.450 to 72.000)	-116.65; (-144.000 to 199.590)	-51.50; (-231.000 to 5.000)	-7.00; (-29.000 to 27.370)
Cycle 2 Day 28	Number Analyzed	48 participants	21 participants	18 participants	5 participants	4 participants	25 participants
		-1.00; (-18.000 to 51.000)	-3.00; (-23.980 to 48.000)	52.00; (-31.000 to 76.000)	-93.00; (-181.270 to 10.430)	9.50; (-260.000 to 245.000)	-3.00; (-23.980 to 48.000)
Cycle 3 Day 1	Number Analyzed	33 participants	17 participants	9 participants	3 participants	4 participants	21 participants
		-23.00; (-66.000 to -3.000)	-10.00; (-37.000 to 10.740)	-11.76; (-75.000 to 58.000)	-104.00; (-111.260 to -66.000)	-80.00; (-378.000 to 189.000)	-23.00; (-66.000 to 10.740)
Cycle 3 Day 15	Number Analyzed	30 participants	16 participants	8 participants	3 participants	3 participants	19 participants
		-33.00; (-70.000 to -2.000)	-27.50; (-63.000 to 41.000)	-46.00; (-75.800 to 158.000)	-99.00; (-153.310 to -24.000)	-84.00; (-97.000 to 88.000)	-29.00; (-67.000 to 41.000)
Cycle 3 Day 28	Number Analyzed	33 participants	18 participants	8 participants	3 participants	4 participants	22 participants
		-15.00; (-32.000 to 11.000)	-5.66; (-28.000 to 51.000)	0.62; (-58.000 to 108.000)	-70.00; (-115.000 to -57.020)	-13.50; (-93.000 to 103.000)	-13.50; (-28.000 to 51.000)
Study Completion/Early Termination	Number Analyzed	43 participants	16 participants	18 participants	5 participants	4 participants	20 participants
		-11.00; (-35.000 to 2.000)	-11.50; (-35.000 to -2.000)	-20.74; (-181.990 to 13.260)	1.15; (-242.000 to 151.000)	22.00; (-463.000 to 1924.000)	-9.00; (-35.000 to 8.000)

22. Secondary Outcome

Title	Percent Change From Baseline in Measurements of NK Cell Populations
Description	Relative change from baseline will be summarized descriptively by visit for the pharmacodynamic parameter: NK cell populations
Time Frame	Cycle 1 Day 1 (Baseline) to Cycle 1: Days 8, 15, and 22; Cycles 2 and 3: Days 1, 15, and 28 (each cycle is 28 days); End of Study (up to 7.5 years)

Outcome Measure Data

Analysis Population Description

Pharmacodynamic samples were collected at timepoints through the study where possible. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		71	26	30	9	6	32
Median (95% Confidence Interval); Unit of Measure: percentage change from baseline
Cycle 1 Day 8	Number Analyzed	64 participants	24 participants	27 participants	8 participants	5 participants	29 participants
		-1.62; (-18.261 to 11.429)	-11.58; (-23.789 to 6.122)	13.16; (-16.393 to 36.190)	-32.20; (-43.326 to 3.990)	13.79; (-48.940 to 194.444)	-8.66; (-23.789 to 13.793)
Cycle 1 Day 15	Number Analyzed	65 participants	26 participants	27 participants	7 participants	5 participants	31 participants
		-18.85; (-24.046 to 11.364)	-22.39; (-29.630 to 17.918)	-1.14; (-21.078 to 33.333)	-25.78; (-50.781 to 103.540)	-32.11; (-49.421 to 183.333)	-22.45; (-32.114 to 17.918)
Cycle 1 Day 22	Number Analyzed	61 participants	23 participants	26 participants	7 participants	5 participants	28 participants
		-13.38; (-29.688 to 3.027)	-13.38; (-39.053 to 3.027)	18.16; (-36.667 to 69.880)	-50.87; (-78.000 to -4.347)	-36.21; (-56.281 to 116.667)	-14.59; (-39.053 to 2.597)
Cycle 2 Day 1	Number Analyzed	58 participants	24 participants	24 participants	5 participants	5 participants	29 participants
		-11.17; (-23.478 to 5.634)	-8.03; (-25.573 to 11.896)	-14.97; (-24.740 to 17.297)	-50.00; (-53.667 to 337.684)	-0.16; (-56.371 to 141.667)	-6.48; (-25.573 to 11.896)
Cycle 2 Day 15	Number Analyzed	53 participants	20 participants	22 participants	7 participants	4 participants	24 participants
		-8.11; (-22.467 to 20.314)	9.03; (-22.467 to 22.727)	-7.13; (-31.429 to 60.000)	-41.00; (-56.250 to 134.731)	-20.08; (-37.684 to 8.621)	-1.51; (-22.467 to 20.370)
Cycle 2 Day 28	Number Analyzed	48 participants	21 participants	18 participants	5 participants	4 participants	25 participants
		-1.92; (-14.762 to 29.730)	-4.23; (-15.909 to 19.592)	32.57; (-14.762 to 73.729)	-48.44; (-68.976 to 6.334)	35.32; (-42.414 to 261.111)	-4.23; (-15.909 to 19.592)
Cycle 3 Day 1	Number Analyzed	33 participants	17 participants	9 participants	3 participants	4 participants	21 participants
		-14.08; (-26.866 to -1.115)	-12.83; (-25.191 to 12.987)	-8.33; (-35.545 to 50.000)	-42.34; (-51.563 to -34.667)	-31.97; (-61.664 to 525.000)	-13.22; (-26.866 to 12.987)
Cycle 3 Day 15	Number Analyzed	30 participants	16 participants	8 participants	3 participants	3 participants	19 participants
		-20.13; (-38.253 to -1.136)	-17.76; (-40.845 to 18.062)	-16.17; (-39.336 to 124.576)	-33.00; (-58.337 to -18.750)	-32.43; (-39.431 to 244.444)	-20.37; (-39.431 to 18.062)
Cycle 3 Day 28	Number Analyzed	33 participants	18 participants	8 participants	3 participants	4 participants	22 participants
		-6.10; (-21.697 to 17.000)	-2.72; (-24.426 to 19.872)	1.78; (-28.409 to 91.525)	-38.33; (-54.688 to -21.697)	-5.37; (-15.171 to 286.111)	-5.37; (-18.182 to 19.872)
Study Completion/Early Termination	Number Analyzed	43 participants	16 participants	18 participants	5 participants	4 participants	20 participants
		-11.01; (-28.906 to 6.667)	-11.06; (-28.333 to -0.866)	-23.94; (-62.726 to 16.667)	0.78; (-80.667 to 86.979)	42.15; (-75.530 to 782.114)	-10.49; (-28.333 to 22.222)

23. Secondary Outcome

Title	Evaluation of AEs Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
Description	Incidence of AEs as stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Time Frame	From first dose until 30 days after last dose of MOR00208, up to 8.5 years

Outcome Measure Data

Analysis Population Description

Per pre-specified analysis plan, if CD19 expression on tumor cells was able to be measured in less than 15% of the ITT population at screening, the stratification analyses by baseline CD19 expression (as planned in the protocol) would not be performed. It was not possible to measure CD19 expression in sufficient cases for such an analysis to be meaningful.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	0	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

24. Secondary Outcome

Title	Evaluation of ORR Stratified by Baseline CD19 Expression on Malignant Lymphoma Cells
Description	The analysis of the primary endpoint (ORR) will additionally be stratified by presence of CD19 on malignant lymphoma cells detected by tumor biopsy/aspirate during Screening
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

Per pre-specified analysis plan, if CD19 expression on tumor cells was able to be measured in less than 15% of the ITT population at screening, the stratification analyses by baseline CD19 expression (as planned in the protocol) would not be performed. It was not possible to measure CD19 expression in sufficient cases for such an analysis to be meaningful.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	0	0	0	0	0	0

No data displayed because Outcome Measure has zero total analyzed.

25. Secondary Outcome

Title	Evaluation of AEs Stratified by FcγRIIa Polymorphism
Description	Incidence of AEs as stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Time Frame	From first dose until 30 days after last dose of MOR00208, up to 8.5 years

Outcome Measure Data

Analysis Population Description

Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	74	25	32	10	7	32
Measure Type: Number; Unit of Measure: adverse events
Genotype HH	210	64	109	29	8	72
Genotype HR	188	83	51	6	48	131
Genotype RR	61	5	44	4	8	13

26. Secondary Outcome

Title	Evaluation of AEs Stratified by FcγRIIIa Polymorphism
Description	Incidence of AEs as stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Time Frame	From first dose until 30 days after last dose of MOR00208, up to 8.5 years

Outcome Measure Data

Analysis Population Description

Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title	Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:	All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed	74	25	32	10	7	32
Measure Type: Number; Unit of Measure: adverse events
Genotype FF	110	51	59	0	0	51
Genotype FV	149	75	33	33	8	83
Genotype VV	200	26	112	6	56	82

27. Secondary Outcome

Title	Evaluation of ORR Stratified by FcγRIIa Polymorphism
Description	The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIa polymorphism subgroups (genotypes HH, HR, or RR)
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		74	25	32	10	7	32
Measure Type: Count of Participants; Unit of Measure: Participants
Genotype HH	Number Analyzed	24 participants	9 participants	11 participants	3 participants	1 participants	10 participants
		6 25.0%	2 22.2%	4 36.4%	0 0.0%	0 0.0%	2 20.0%
Genotype HR	Number Analyzed	32 participants	13 participants	9 participants	6 participants	4 participants	17 participants
		8 25.0%	3 23.1%	3 33.3%	0 0.0%	2 50.0%	5 29.4%
Genotype RR	Number Analyzed	18 participants	3 participants	12 participants	1 participants	2 participants	5 participants
		3 16.7%	0 0.0%	2 16.7%	0 0.0%	1 50.0%	1 20.0%

28. Secondary Outcome

Title	Evaluation of ORR Stratified by FcγRIIIa Polymorphism
Description	The analysis of the primary endpoint (ORR) will additionally be stratified by FcγRIIIa polymorphism subgroups (genotypes FF, FV, or VV)
Time Frame	From first dose until Follow-up Visit 12, up to 4.5 years

Outcome Measure Data

Analysis Population Description

Genotyping for FcγRIIa and FcγRIIIa polymorphisms was performed for patients who consented to an optional mucosal cheek swab. Per pre-specified analysis plan, statistical summaries are provided overall, by NHL subtype, and for the combined group comprising FL patients + other iNHL patients.

Arm/Group Title		Total	FL Subtype	DLBCL Subtype	MCL Subtype	Other iNHL	FL + Other iNHL
Arm/Group Description:		All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.	Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.
Overall Number of Participants Analyzed		74	25	32	10	7	32
Measure Type: Count of Participants; Unit of Measure: Participants
Genotype FF	Number Analyzed	34 participants	9 participants	17 participants	3 participants	5 participants	14 participants
		10 29.4%	1 11.1%	6 35.3%	0 0.0%	3 60.0%	4 28.6%
Genotype FV	Number Analyzed	30 participants	12 participants	10 participants	6 participants	2 participants	14 participants
		5 16.7%	2 16.7%	3 30.0%	0 0.0%	0 0.0%	2 14.3%
Genotype VV	Number Analyzed	10 participants	4 participants	5 participants	1 participants	0 participants	4 participants
		2 20.0%	2 50.0%	0 0.0%	0 0.0%	0	2 50.0%

Adverse Events

Time Frame

Adverse events were collected from informed consent until 30 days after last dose of MOR00208, up to 8.5 years

Adverse Event Reporting Description

Patients were closely monitored for any kind of AE during the study. AEs were detected through physical examination, laboratory tests, or other assessments, or when volunteered by the patient in response to non-leading questioning during or between study visits. All SAEs are reported for the Safety Population, including events occurring prior to first dose of MOR00208. For non-serious AEs, only treatment-emergent events are reported (i.e., events occurring after first dose of MOR00208).

Arm/Group Title

Total

FL Subtype

DLBCL Subtype

MCL Subtype

Other iNHL

FL + Other iNHL

Arm/Group Description

All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Patients with follicular lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Patients with diffuse large B-cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Patients with mantle cell lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

Combined group of patients with follicular lymphoma and patients with other indolent non-Hodgkin's lymphoma. All patients received 12 mg/kg MOR00208 administered as an intravenous infusion.

All-Cause Mortality

Total

FL Subtype

DLBCL Subtype

MCL Subtype

Other iNHL

FL + Other iNHL

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

9/92 (9.78%)

1/34 (2.94%)

6/35 (17.14%)

2/12 (16.67%)

0/11 (0.00%)

1/45 (2.22%)

Serious Adverse Events

Total

FL Subtype

DLBCL Subtype

MCL Subtype

Other iNHL

FL + Other iNHL

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

30/92 (32.61%)

7/34 (20.59%)

18/35 (51.43%)

2/12 (16.67%)

3/11 (27.27%)

10/45 (22.22%)

Blood and lymphatic system disorders

Anaemia † 1

2/92 (2.17%)

4

0/34 (0.00%)

0

2/35 (5.71%)

4

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Febrile neutropenia † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Cardiac disorders

Cardiac failure † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Eye disorders

Vision blurred † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Gastrointestinal disorders

Abdominal pain upper † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Colitis † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Gastrointestinal haemorrhage † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

General disorders

Disease progression † 1

11/92 (11.96%)

12

2/34 (5.88%)

3

6/35 (17.14%)

6

2/12 (16.67%)

2

1/11 (9.09%)

1

3/45 (6.67%)

4

Hepatobiliary disorders

Cholecystitis acute † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Infections and infestations

Device related infection † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Genital herpes zoster † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Herpes zoster † 1

2/92 (2.17%)

2

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

1/11 (9.09%)

1

1/45 (2.22%)

1

Infected bite † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Pneumococcal infection † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Pneumonia † 1

3/92 (3.26%)

5

0/34 (0.00%)

0

3/35 (8.57%)

5

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Respiratory tract infection † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Injury, poisoning and procedural complications

Fracture † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

0/35 (0.00%)

0

0/12 (0.00%)

0

1/11 (9.09%)

1

1/45 (2.22%)

1

Infusion related reaction † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Bone cancer † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Myelodysplastic syndrome † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Renal and urinary disorders

Acute kidney injury † 1

1/92 (1.09%)

1

1/34 (2.94%)

1

0/35 (0.00%)

0

0/12 (0.00%)

0

0/11 (0.00%)

0

1/45 (2.22%)

1

Ureterolithiasis † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

Respiratory, thoracic and mediastinal disorders

Respiratory failure † 1

1/92 (1.09%)

1

0/34 (0.00%)

0

1/35 (2.86%)

1

0/12 (0.00%)

0

0/11 (0.00%)

0

0/45 (0.00%)

0

1 Term from vocabulary, MedDRA Version 24.0; † Indicates events were collected by systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

5%

Total

FL Subtype

DLBCL Subtype

MCL Subtype

Other iNHL

FL + Other iNHL

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Affected / at Risk (%)

# Events

Total

77/92 (83.70%)

27/34 (79.41%)

31/35 (88.57%)

9/12 (75.00%)

10/11 (90.91%)

37/45 (82.22%)

Blood and lymphatic system disorders

Neutropenia † 1

9/92 (9.78%)

12

2/34 (5.88%)

2

5/35 (14.29%)

8

1/12 (8.33%)

1

1/11 (9.09%)

1

3/45 (6.67%)

3

Thrombocytopenia † 1

5/92 (5.43%)

14

0/34 (0.00%)

0

4/35 (11.43%)

12

1/12 (8.33%)

2

0/11 (0.00%)

0

0/45 (0.00%)

0

Lymphadenopathy † 1

6/92 (6.52%)

9

2/34 (5.88%)

4

3/35 (8.57%)

4

1/12 (8.33%)

1

0/11 (0.00%)

0

2/45 (4.44%)

4

Gastrointestinal disorders

Nausea † 1

9/92 (9.78%)

11

4/34 (11.76%)

6

2/35 (5.71%)

2

0/12 (0.00%)

0

3/11 (27.27%)

3

7/45 (15.56%)

9

Diarrhoea † 1

8/92 (8.70%)

9

2/34 (5.88%)

2

5/35 (14.29%)

6

0/12 (0.00%)

0

1/11 (9.09%)

1

3/45 (6.67%)

3

Constipation † 1

6/92 (6.52%)

7

2/34 (5.88%)

2

2/35 (5.71%)

3

1/12 (8.33%)

1

1/11 (9.09%)

1

3/45 (6.67%)

3

General disorders

Fatigue † 1

8/92 (8.70%)

12

3/34 (8.82%)

5

3/35 (8.57%)

5

0/12 (0.00%)

0

2/11 (18.18%)

2

5/45 (11.11%)

7

Oedema peripheral † 1

8/92 (8.70%)

9

2/34 (5.88%)

2

5/35 (14.29%)

5

1/12 (8.33%)

2

0/11 (0.00%)

0

2/45 (4.44%)

2

Asthenia † 1

7/92 (7.61%)

9

3/34 (8.82%)

5

3/35 (8.57%)

3

1/12 (8.33%)

1

0/11 (0.00%)

0

3/45 (6.67%)

5

Pyrexia † 1

5/92 (5.43%)

8

2/34 (5.88%)

2

1/35 (2.86%)

2

1/12 (8.33%)

1

1/11 (9.09%)

3

3/45 (6.67%)

5

Infections and infestations

Upper respiratory tract infection † 1

11/92 (11.96%)

14

7/34 (20.59%)

9

4/35 (11.43%)

5

0/12 (0.00%)

0

0/11 (0.00%)

0

7/45 (15.56%)

9

Bronchitis † 1

6/92 (6.52%)

8

1/34 (2.94%)

1

4/35 (11.43%)

5

0/12 (0.00%)

0

1/11 (9.09%)

2

2/45 (4.44%)

3

Injury, poisoning and procedural complications

Infusion-related reaction † 1

12/92 (13.04%)

15

4/34 (11.76%)

4

4/35 (11.43%)

6

2/12 (16.67%)

2

2/11 (18.18%)

3

6/45 (13.33%)

7

Musculoskeletal and connective tissue disorders

Back pain † 1

7/92 (7.61%)

7

2/34 (5.88%)

2

2/35 (5.71%)

2

1/12 (8.33%)

1

2/11 (18.18%)

2

4/45 (8.89%)

4

Nervous system disorders

Headache † 1

10/92 (10.87%)

15

3/34 (8.82%)

3

4/35 (11.43%)

7

1/12 (8.33%)

1

2/11 (18.18%)

4

5/45 (11.11%)

7

Dizziness † 1

9/92 (9.78%)

11

4/34 (11.76%)

4

2/35 (5.71%)

3

0/12 (0.00%)

0

3/11 (27.27%)

4

7/45 (15.56%)

8

Psychiatric disorders

Insomnia † 1

7/92 (7.61%)

8

4/34 (11.76%)

5

1/35 (2.86%)

1

2/12 (16.67%)

2

0/11 (0.00%)

0

4/45 (8.89%)

5

Respiratory, thoracic and mediastinal disorders

Cough † 1

8/92 (8.70%)

14

2/34 (5.88%)

3

4/35 (11.43%)

8

0/12 (0.00%)

0

2/11 (18.18%)

3

4/45 (8.89%)

6

Dyspnoea † 1

7/92 (7.61%)

9

0/34 (0.00%)

0

4/35 (11.43%)

6

2/12 (16.67%)

2

1/11 (9.09%)

1

1/45 (2.22%)

1

1 Term from vocabulary, MedDRA Version 24.0; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Medical Information
• Organization: MorphoSys AG
• Phone: +1 844 667-1992
• EMail: medinfo@morphosys.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jurczak W, Zinzani PL, Gaidano G, Goy A, Provencio M, Nagy Z, Robak T, Maddocks K, Buske C, Ambarkhane S, Winderlich M, Dirnberger-Hertweck M, Korolkiewicz R, Blum KA. Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. Ann Oncol. 2018 May 1;29(5):1266-1272. doi: 10.1093/annonc/mdy056.

• Responsible Party: MorphoSys AG
• ClinicalTrials.gov Identifier: NCT01685008
• Other Study ID Numbers: MOR208C201; 2012-002659-41 ( EudraCT Number )
• First Submitted: September 3, 2012
• First Posted: September 13, 2012
• Results First Submitted: April 5, 2023
• Results First Posted: November 7, 2023
• Last Update Posted: November 7, 2023