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Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) (ZUMA-2)

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ClinicalTrials.gov Identifier: NCT02601313
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : September 10, 2020
Last Update Posted : February 12, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences ( Kite, A Gilead Company )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Relapsed/Refractory Mantle Cell Lymphoma
Interventions Biological: brexucabtagene autoleucel
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Axicabtagene Ciloleucel
Enrollment 105
Recruitment Details Participants were enrolled at study sites in United States, France, Netherlands and Germany. The first participant was screened on 09 Nov 2015. The data cutoff occurred on 24 July 2019.
Pre-assignment Details Participants from 2 x 10^6 axicabtagene ciloleucel (AC) didn't contribute to primary and secondary analysis. The process used to manufacture axicabtagene ciloleucel was modified to manufacture brexucabtagene autoleucel (KTE-X19). 10 participants were treated with axicabtagene ciloleucel, all other participants were treated with KTE-X19.
Arm/Group Title 2 x 10^6 Axicabtagene Ciloleucel Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description Participants with relapsed/refractory mantle cell lymphoma (MCL) received conditioning chemotherapy (CTE) consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day intravenous (IV) infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 chimeric antigen receptor (CAR) T cells/kg on Day 0. Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0. Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Period Title: Overall Study
Started 14 74 17
Completed 8 0 0
Not Completed 6 74 17
Reason Not Completed
Death             2             16             4
Enrolled, did not initiate CTE/KTE-X19             0             5             2
Enrolled, did not initiate KTE-X19             0             1             1
Still on study             0             52             10
Enrolled, did not initiate AC             4             0             0
Arm/Group Title 2 x 10^6 Axicabtagene Ciloleucel Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel Total
Hide Arm/Group Description Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg on Day 0. Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0. Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0. Total of all reporting groups
Overall Number of Baseline Participants 10 68 14 92
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants treated with any dose of anti-CD19 CAR T cells.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 10 participants 68 participants 14 participants 92 participants
< 65 years 4 29 11 44
>= 65 years 6 39 3 48
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 68 participants 14 participants 92 participants
Female 1 11 3 15
Male 9 57 11 77
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 68 participants 14 participants 92 participants
Hispanic or Latino 0 11 2 13
Not Hispanic or Latino 9 55 12 76
Unknown or Not Reported 1 2 0 3
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 10 participants 68 participants 14 participants 92 participants
Black or African American 0 1 0 1
White 10 62 13 85
Native Hawaiian or other Pacific Islander 0 1 0 1
Others 0 4 1 5
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 10 participants 68 participants 14 participants 92 participants
Netherlands 0 2 0 2
United States 10 62 14 86
France 0 3 0 3
Germany 0 1 0 1
1.Primary Outcome
Title Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 1
Hide Description OR: complete metabolic response(CMR),complete radiological response(CRR),partial MR response(PMR),partial RR(PRR).CMR:score 1(no uptake above background)/2(uptake ≤ mediastinum)/3(uptake > mediastinum but ≤ liver)with/without a residual mass on positron emission tomography 5-point scale;no new lesions.CRR:target nodes/nodal masses regressed to ≤ 1.5 cm in longest transverse diameter of lesion(LDi);no extralymphatic sites of disease;absent non-measured lesion(NMLs);organ enlargement regress to normal;no new sites;bone marrow normal by morphology. PMR:score 4(uptake moderately > liver)/5(uptake markedly > liver, new lesions)with reduced uptake compared with baseline and residual mass;no new lesions;responding disease at interim/residual disease at end of treatment (EOT).PRR: ≥ 50% decrease in sum of the product of the diameters(SPD)of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs;spleen regressed by > 50% in length beyond normal.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Inferential Analysis Set included the first 60 treated brexucabtagene autoleucel participants in Cohort 1.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: percentage of participants
93
2.Primary Outcome
Title Percentage of Participants With Objective Response (OR) Per the Lugano Classification According to Independent Radiology Review Committee (IRRC) in Cohort 2
Hide Description OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake > mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi; no extralymphatic sites of disease;absent non-measured lesion NMLs; organ enlargement regress to normal; no new sites; bone marrow normal by morphology. PMR: score 4(uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. PRR: ≥ 50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites; absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The Modified intent to Treat (mITT) analysis set included all enrolled participants treated with any dose of anti-CD19 CAR T cells.
Arm/Group Title Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: percentage of participants
93
3.Secondary Outcome
Title Duration of Response (DOR) in Cohort 1
Hide Description DOR: time from the first OR to progressive disease (PD)/death. It is determined using Kaplan-Meier (KM) estimates. PD: score 4 (uptake moderately > liver)/ 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by ≥ 50% from cross-product of LDi and perpendicular diameter (PPD) nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Duration of Response (DOR) in Cohort 2
Hide Description DOR: time from the first OR to PD/death. It is determined using KM estimates. PD: score 4 (uptake moderately > liver)/5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim/EOT assessment; new FDG-avid foci consistent with lymphoma rather than another etiology; new/recurrent FDG-avid foci in bone marrow; an individual node/lesion must be abnormal with: LDi > 1.5 cm, increase by ≥ 50% from cross-product of LDi and PPD nadir, increase in LDi or shortest axis perpendicular to the LDi from nadir, the splenic length must increase by > 50% of the extent of its prior increase beyond baseline. If no prior splenomegaly, the increase must be ≥ 2 cm from baseline; new/recurrent splenomegaly; new or clear progression of pre-existing NMLs; new lesion; new/recurrent bone marrow involvement.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1
Hide Description BOR consists of (Complete response [CR], Partial response [PR], stable disease [SD], progressive disease [PD] and unknown). CR: disappearance of all detectable clinical evidence; PR: 50% decrease in the sum of the product of diameters (SPD) of up to 6 largest dominant nodal masses and >= 50% decrease in SPD of spleen/liver nodules; PD: appearance of any new lesions or >= 50% increase in SPD of more than one node or >= 50% increase in longest diameter of a previously identified node or >50% increase from nadir in the SPD of any previous lesions; SD: failure to attain CR/PR or PD.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Percentage of Participants With Best Objective Response (BOR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2
Hide Description BOR consists of CR (CMR/CRR), PR (PMR/PRR), SD, PD and not done. CMR/CRR and PMR/PRR are defined in Outcome Measure (OM) 1. PD is defined in OM 3. SD/no metabolic response (NMR): a score 4 (uptake moderately greater than [>] liver) or 5 (uptake markedly >liver and/ or new lesions) with no significant change in FDG uptake compared to baseline (screening), at an interim time point or end of treatment; no new sites of disease should be observed.Not done: no assessment at the time of analysis.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by International Working Group (IWG) 2007 Criteria in Cohort 1
Hide Description OR: CR or PR. CR: disappearance of all detectable clinical evidence; typically FDG-avid lymphoma (a post-treatment residual mass of any size is permitted if it is PET negative); variably FDG-avid lymphomas/FDG avidity unknown (all lymph nodes and nodal masses must have regressed to normal size); spleen and/or liver should be normal size and not be palpable; bone marrow aspirate and biopsy must show no evidence of disease. PR: 50% decrease in the SPD of up to 6 largest dominant nodal masses and ≥ 50% decrease in SPD of spleen/liver nodules; no increase in size of nodes, liver, or spleen and no new sites of disease; splenic and hepatic nodules must regress by ≥ 50% in the SPD; if participant has persistent bone marrow involvement and otherwise meets criteria for CR, will then be considered a PR; typically FDG-avid lymphoma (the post-treatment PET scan should be positive in at least 1 previously involved site.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Participants With Objective Response (OR) as Per Investigator Assessment Determined by Lugano Classification in Cohort 2
Hide Description OR: CMR, CRR, PMR, PRR. CMR: score 1(no uptake above background) / 2(uptake ≤ mediastinum) / 3(uptake > mediastinum but ≤ liver) with/without a residual mass on positron emission tomography 5-point scale; no new lesions. CRR: target nodes/nodal masses regressed to ≤ 1.5 cm in LDi ;no extralymphatic sites of disease;absent NMLs; organ enlargement regress to normal; no new sites;bone marrow normal by morphology. PMR: score 4 (uptake moderately > liver) /5 (uptake markedly > liver, new lesions) with reduced uptake compared with baseline and residual mass; no new lesions; responding disease at interim/residual disease at EOT. PRR: ≥ 50% decrease in SPD of up to 6 target measurable nodes and extra-nodal sites;absent/normal, regressed, but no increase of NMLs; spleen regressed by > 50% in length beyond normal.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Progression Free Survival (PFS) in Cohort 1
Hide Description PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately > liver) or 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Progression Free Survival (PFS) in Cohort 2
Hide Description PFS was defined as the time from the brexucabtagene autoleucel infusion date to the date of PD or death from any cause. PD: a score 4 (uptake moderately > liver) or 5 (uptake markedly >liver and/or new lesions) with an increase in intensity of uptake from baseline; new FDG-avid foci consistent with lymphoma at interim or end of treatment assessment; new FDG-avid foci consistent with lymphoma rather than another etiology (eg, infection, inflammation); new or recurrent FDG-avid foci in bone marrow. PFS was determined using the KM estimates.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Overall Survival in Cohort 1
Hide Description Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Overall Survival in Cohort 2
Hide Description Overall survival was defined as the time from brexucabtagene autoleucel infusion to the date of death from any cause. Overall survival was determined using the KM estimates.
Time Frame Up to 15 years
Outcome Measure Data Not Reported
13.Secondary Outcome
Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
14.Secondary Outcome
Title Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Hematology Toxicity Values by Worst Toxicity Grade
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
16.Secondary Outcome
Title Percentage of Participants With Decrease in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Percentage of Participants With Increase in Post-brexucabtagene Autoleucel Infusion Chemistry Toxicity Values by Worst Toxicity Grade
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
18.Secondary Outcome
Title Percentage of Participants With Anti-CD19 CAR Antibodies
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
19.Secondary Outcome
Title Peak Anti-CD19 CAR T-Cell (Brexucabtagene Autoleucel) Level (Maximum Observed Plasma Concentration) in Blood
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Peak Serum Levels of C-Reactive Protein (CRP) in Blood
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
21.Secondary Outcome
Title Peak Serum Levels of C-X-C Motif Chemokine 10 (CXCL10), Granzyme B, Interferon-Gamma (IFN-γ), Interleukin-1 Receptor Antagonist (IL-1RA), Interleukin (IL)-2, IL-6, IL-7, IL-8,IL-10, IL-15, and Tumor Necrosis Factor-Alpha (TNF-α) in Blood
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
22.Secondary Outcome
Title Peak Serum Levels of Ferritin, Interleukin-2 Receptor Alpha (IL-2Rα), Intercellular Adhesion Molecule-1 (ICAM-1), Perforin, Vascular Cell Adhesion Molecule-1 (VCAM-1) in Blood
Hide Description [Not Specified]
Time Frame Up to 15 years
Outcome Measure Data Not Reported
23.Secondary Outcome
Title Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Mobility Scale Score
Hide Description The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported.
Time Frame Baseline, Week 4, Month 3, and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 62 12
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: No problems walking Number Analyzed 62 participants 12 participants
85 83
Baseline: Slight problems walking Number Analyzed 62 participants 12 participants
11 17
Baseline: Moderate problems walking Number Analyzed 62 participants 12 participants
3 0
Baseline: Severe problems walking Number Analyzed 62 participants 12 participants
0 0
Baseline: Unable to walk Number Analyzed 62 participants 12 participants
0 0
Week 4: No problems walking Number Analyzed 51 participants 11 participants
49 73
Week 4: Slight problems walking Number Analyzed 51 participants 11 participants
33 9
Week 4: Moderate problems walking Number Analyzed 51 participants 11 participants
6 18
Week 4: Severe problems walking Number Analyzed 51 participants 11 participants
8 0
Week 4: Unable to walk Number Analyzed 51 participants 11 participants
4 0
Month 3: No problems walking Number Analyzed 54 participants 11 participants
69 91
Month 3: Slight problems walking Number Analyzed 54 participants 11 participants
19 9
Month 3: Moderate problems walking Number Analyzed 54 participants 11 participants
7 0
Month 3: Severe problems walking Number Analyzed 54 participants 11 participants
4 0
Month 3: Unable to walk Number Analyzed 54 participants 11 participants
2 0
Month 6: No problems walking Number Analyzed 40 participants 10 participants
75 90
Month 6: Slight problems walking Number Analyzed 40 participants 10 participants
13 10
Month 6: Moderate problems walking Number Analyzed 40 participants 10 participants
8 0
Month 6: Severe problems walking Number Analyzed 40 participants 10 participants
5 0
Month 6: Unable to walk Number Analyzed 40 participants 10 participants
0 0
24.Secondary Outcome
Title Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Self-Care Scale Score
Hide Description The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported.
Time Frame Baseline, Week 4, Month 3, and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 62 12
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: No problems washing or dressing, Number Analyzed 62 participants 12 participants
95 100
Baseline: Slight problems washing or dressing Number Analyzed 62 participants 12 participants
3 0
Baseline: Moderate problems washing or dressing Number Analyzed 62 participants 12 participants
2 0
Baseline: Severe problems washing or dressing Number Analyzed 62 participants 12 participants
0 0
Baseline: Unable to wash or dress Number Analyzed 62 participants 12 participants
0 0
Week 4: No problems washing or dressing, Number Analyzed 52 participants 11 participants
67 91
Week 4: Slight problems washing or dressing Number Analyzed 52 participants 11 participants
17 9
Week 4: Moderate problems washing or dressing Number Analyzed 52 participants 11 participants
4 0
Week 4: Severe problems washing or dressing Number Analyzed 52 participants 11 participants
8 0
Week 4: Unable to wash or dress Number Analyzed 52 participants 11 participants
4 0
Month 3: No problems washing or dressing, Number Analyzed 54 participants 11 participants
83 100
Month 3: Slight problems washing or dressing Number Analyzed 54 participants 11 participants
11 0
Month 3: Moderate problems washing or dressing Number Analyzed 54 participants 11 participants
4 0
Month 3: Severe problems washing or dressing Number Analyzed 54 participants 11 participants
2 0
Month 3: Unable to wash or dress Number Analyzed 54 participants 11 participants
0 0
Month 6: No problems washing or dressing, Number Analyzed 40 participants 10 participants
93 100
Month 6: Slight problems washing or dressing Number Analyzed 40 participants 10 participants
3 0
Month 6: Moderate problems washing or dressing Number Analyzed 40 participants 10 participants
0 0
Month 6: Severe problems washing or dressing Number Analyzed 40 participants 10 participants
5 0
Month 6: Unable to wash or dress Number Analyzed 40 participants 10 participants
0 0
25.Secondary Outcome
Title Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Usual Activity Scale Score
Hide Description The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported.
Time Frame Baseline, Week 4, Month 3, and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 65 12
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: No problems doing usual activities Number Analyzed 65 participants 12 participants
82 75
Baseline: Slight problems doing usual activities Number Analyzed 65 participants 12 participants
14 17
Baseline: Moderate problems doing usual activities Number Analyzed 65 participants 12 participants
5 8
Baseline: Severe problems doing usual activities Number Analyzed 65 participants 12 participants
0 0
Baseline: Unable to do usual activities Number Analyzed 65 participants 12 participants
0 0
Week 4: No problems doing usual activities Number Analyzed 51 participants 11 participants
43 36
Week 4: Slight problems doing usual activities Number Analyzed 51 participants 11 participants
24 55
Week 4: Moderate problems doing usual activities Number Analyzed 51 participants 11 participants
22 9
Week 4: Severe problems doing usual activities Number Analyzed 51 participants 11 participants
6 0
Week 4: Unable to do usual activities Number Analyzed 51 participants 11 participants
6 0
Month 3: No problems doing usual activities Number Analyzed 55 participants 11 participants
69 64
Month 3: Slight problems doing usual activities Number Analyzed 55 participants 11 participants
16 36
Month 3: Moderate problems doing usual activities Number Analyzed 55 participants 11 participants
7 0
Month 3: Severe problems doing usual activities Number Analyzed 55 participants 11 participants
4 0
Month 3: Unable to do usual activities Number Analyzed 55 participants 11 participants
4 0
Month 6: No problems doing usual activities Number Analyzed 41 participants 10 participants
73 70
Month 6: Slight problems doing usual activities Number Analyzed 41 participants 10 participants
17 30
Month 6: Moderate problems doing usual activities Number Analyzed 41 participants 10 participants
7 0
Month 6: Severe problems doing usual activities Number Analyzed 41 participants 10 participants
0 0
Month 6: Unable to do usual activities Number Analyzed 41 participants 10 participants
2 0
26.Secondary Outcome
Title Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Pain / Discomfort Activity Scale Score
Hide Description The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The percentage of participants with each level of problem are reported.
Time Frame Baseline, Week 4, Month 3, and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 65 12
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: No pain or discomfort Number Analyzed 65 participants 12 participants
66 75
Baseline: Slight pain or discomfort Number Analyzed 65 participants 12 participants
22 8
Baseline: Moderate pain or discomfort Number Analyzed 65 participants 12 participants
9 17
Baseline: Severe pain or discomfort Number Analyzed 65 participants 12 participants
3 0
Baseline: Extreme pain or discomfort Number Analyzed 65 participants 12 participants
0 0
Week 4: No pain or discomfort Number Analyzed 54 participants 11 participants
63 64
Week 4: Slight pain or discomfort Number Analyzed 54 participants 11 participants
19 18
Week 4: Moderate pain or discomfort Number Analyzed 54 participants 11 participants
19 18
Week 4: Severe pain or discomfort Number Analyzed 54 participants 11 participants
0 0
Week 4: Extreme pain or discomfort Number Analyzed 54 participants 11 participants
0 0
Month 3: No pain or discomfort Number Analyzed 55 participants 11 participants
60 64
Month 3: Slight pain or discomfort Number Analyzed 55 participants 11 participants
16 27
Month 3: Moderate pain or discomfort Number Analyzed 55 participants 11 participants
18 9
Month 3: Severe pain or discomfort Number Analyzed 55 participants 11 participants
4 0
Month 3: Extreme pain or discomfort Number Analyzed 55 participants 11 participants
2 0
Month 6: No pain or discomfort Number Analyzed 42 participants 10 participants
67 70
Month 6: Slight pain or discomfort Number Analyzed 42 participants 10 participants
21 10
Month 6: Moderate pain or discomfort Number Analyzed 42 participants 10 participants
10 20
Month 6: Severe pain or discomfort Number Analyzed 42 participants 10 participants
2 0
Month 6: Extreme pain or discomfort Number Analyzed 42 participants 10 participants
0 0
27.Secondary Outcome
Title Change Over Time in European Quality of Life-5 Dimensions(EQ-5D) Anxiety / Depression Activity Scale Score
Hide Description The European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) is a participant-answered questionnaire scoring 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. For each dimension the participant is asked for a three-level assessment of their health on the current day: "no problems" (1), "some problems" (2), "extreme problems" (3). EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 (worst health state) to 1.00 (perfect health state). Positive numbers indicate improvement from baseline. The Percentage of participants with each level of problem are reported.
Time Frame Baseline, Week 4, Month 3, and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 65 12
Measure Type: Number
Unit of Measure: percentage of participants
Baseline: Not anxious or depressed Number Analyzed 65 participants 12 participants
75 67
Baseline: Slight anxious or depressed Number Analyzed 65 participants 12 participants
20 33
Baseline: Moderate anxious or depressed Number Analyzed 65 participants 12 participants
5 0
Baseline: Severe anxious or depressed Number Analyzed 65 participants 12 participants
0 0
Baseline: Extreme anxious or depressed Number Analyzed 65 participants 12 participants
0 0
Week 4: Not anxious or depressed Number Analyzed 54 participants 11 participants
67 73
Week 4: Slight anxious or depressed Number Analyzed 54 participants 11 participants
26 27
Week 4: Moderate anxious or depressed Number Analyzed 54 participants 11 participants
6 0
Week 4: Severe anxious or depressed Number Analyzed 54 participants 11 participants
2 0
Week 4: Extreme anxious or depressed Number Analyzed 54 participants 11 participants
0 0
Month 3: Not anxious or depressed Number Analyzed 55 participants 11 participants
69 91
Month 3: Slight anxious or depressed Number Analyzed 55 participants 11 participants
22 9
Month 3: Moderate anxious or depressed Number Analyzed 55 participants 11 participants
9 0
Month 3: Severe anxious or depressed Number Analyzed 55 participants 11 participants
0 0
Month 3: Extreme anxious or depressed Number Analyzed 55 participants 11 participants
0 0
Month 6: Not anxious or depressed Number Analyzed 42 participants 10 participants
62 90
Month 6: Slight anxious or depressed Number Analyzed 42 participants 10 participants
26 10
Month 6: Moderate anxious or depressed Number Analyzed 42 participants 10 participants
12 0
Month 6: Severe anxious or depressed Number Analyzed 42 participants 10 participants
0 0
Month 6: Extreme anxious or depressed Number Analyzed 42 participants 10 participants
0 0
28.Secondary Outcome
Title Change Over Time in EQ-5D Visual Analogue Scale (VAS) Score
Hide Description EQ-5D is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-consists of two components: a health state profile and an optional visual analogue scale (VAS). The EQ5D-VAS records the participant's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. EQ-5D-VAS: range 0 to 100. A higher score indicates better self-reported health status. A positive change indicates an improvement.
Time Frame Baseline, Week 4, Month 3, and Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description:
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
Overall Number of Participants Analyzed 65 12
Mean (Standard Deviation)
Unit of Measure: scores on the scale
Baseline Number Analyzed 65 participants 12 participants
82.0  (15.4) 82.8  (16.1)
Week 4 Number Analyzed 52 participants 11 participants
74.5  (15.6) 71.4  (19.4)
Month 3 Number Analyzed 55 participants 11 participants
80.1  (15.6) 86.4  (11.0)
Month 6 Number Analyzed 42 participants 10 participants
84.8  (17.5) 89.9  (8.0)
Time Frame From axicabtagene ciloleucel infusion to data cutoff (maximum: 44.16 months).
Adverse Event Reporting Description The Safety Analysis Set included all participants treated with any dose of anti-CD19 CAR T cells. 2 x 10^6 Axicabtagene Ciloleucel: MedDRA version 21.1; Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel and Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel: MedDRA version 22.0
 
Arm/Group Title 2 x 10^6 Axicabtagene Ciloleucel Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Hide Arm/Group Description Participants with relapsed/refractory MCL received CTE consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of axicabtagene ciloleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg on Day 0. Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 2 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 2 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0. Participants with relapsed/refractory MCL received conditioning chemotherapy consisting of fludarabine 30 mg/m^2/day and cyclophosphamide 500 mg/m^2/day IV infusion for 3 days followed by a single infusion of brexucabtagene autoleucel at a targeted dose of 0.5 x 10^6 anti-CD19 CAR T cells/kg, with a maximum dose of 0.5 x 10^8 anti-CD19 CAR T cells for participants ≥ 100 kg on Day 0.
All-Cause Mortality
2 x 10^6 Axicabtagene Ciloleucel Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   16/68 (23.53%)   4/14 (28.57%) 
Hide Serious Adverse Events
2 x 10^6 Axicabtagene Ciloleucel Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   46/68 (67.65%)   8/14 (57.14%) 
Blood and lymphatic system disorders       
Anaemia † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Bone marrow failure † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Neutropenia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Thrombocytopenia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Cardiac disorders       
Atrial fibrillation † 1  1/10 (10.00%)  1/68 (1.47%)  1/14 (7.14%) 
Atrial flutter † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Cardiac arrest † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Supraventricular tachycardia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Tachycardia † 1  0/10 (0.00%)  3/68 (4.41%)  0/14 (0.00%) 
Ventricular arrhythmia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders       
Autoimmune colitis † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Diarrhoea † 1  0/10 (0.00%)  0/68 (0.00%)  2/14 (14.29%) 
Dysphagia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Pancreatic haemorrhage † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Pancreatitis † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Stomatitis necrotising † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Vomiting † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
General disorders       
Chills † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Fatigue † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Generalised oedema † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Malaise † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Multiple organ dysfunction syndrome † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Pyrexia † 1  1/10 (10.00%)  15/68 (22.06%)  2/14 (14.29%) 
Systemic inflammatory response syndrome † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Immune system disorders       
Anaphylactic reaction † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Infections and infestations       
Appendicitis † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Arthritis infective † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Bronchitis † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Corynebacterium infection † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Cytomegalovirus infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Device related infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Enterococcal infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Lung infection † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Nocardiosis † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Parvovirus infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Pneumonia † 1  1/10 (10.00%)  5/68 (7.35%)  1/14 (7.14%) 
Rash pustular † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Respiratory syncytial virus infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Sepsis † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Septic shock † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Skin infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Soft tissue infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Staphylococcal bacteraemia † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Streptococcal bacteraemia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Urinary tract infection † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Wound infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Injury, poisoning and procedural complications       
Femur fracture † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Investigations       
Alanine aminotransferase increased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Aspartate aminotransferase increased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Blood creatinine increased † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
C-reactive protein increased † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Ejection fraction decreased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
International normalised ratio increased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Platelet count decreased † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Serum ferritin increased † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Transaminases increased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Urine output decreased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
White blood cell count decreased † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Metabolism and nutrition disorders       
Dehydration † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Hypernatraemia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Hyponatraemia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Hypophosphataemia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Malnutrition † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Metabolic acidosis † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders       
Back pain † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Joint effusion † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Myopathy † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
B-cell lymphoma † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Leukaemia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Second primary malignancy † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Nervous system disorders       
Aphasia † 1  0/10 (0.00%)  3/68 (4.41%)  1/14 (7.14%) 
Brain oedema † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Dizziness † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Encephalopathy † 1  4/10 (40.00%)  15/68 (22.06%)  1/14 (7.14%) 
Headache † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Intensive care unit acquired weakness † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Lethargy † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Neurotoxicity † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Seizure † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Somnolence † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Tremor † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Psychiatric disorders       
Communication disorder † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Confusional state † 1  1/10 (10.00%)  5/68 (7.35%)  0/14 (0.00%) 
Mental status changes † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Renal and urinary disorders       
Acute kidney injury † 1  0/10 (0.00%)  5/68 (7.35%)  0/14 (0.00%) 
Hydronephrosis † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory distress syndrome † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Dyspnoea † 1  0/10 (0.00%)  2/68 (2.94%)  1/14 (7.14%) 
Hypoxia † 1  1/10 (10.00%)  8/68 (11.76%)  0/14 (0.00%) 
Mediastinal haemorrhage † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Organising pneumonia † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Pleural effusion † 1  0/10 (0.00%)  3/68 (4.41%)  1/14 (7.14%) 
Pulmonary embolism † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Pulmonary oedema † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Respiratory failure † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Dry skin † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Vascular disorders       
Deep vein thrombosis † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Distributive shock † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
Hypertension † 1  0/10 (0.00%)  2/68 (2.94%)  0/14 (0.00%) 
Hypotension † 1  2/10 (20.00%)  11/68 (16.18%)  3/14 (21.43%) 
Shock haemorrhagic † 1  0/10 (0.00%)  1/68 (1.47%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA 21.1 and 22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2 x 10^6 Axicabtagene Ciloleucel Cohort 1: 2 x 10^6 Brexucabtagene Autoleucel Cohort 2: 0.5 x 10^8 Brexucabtagene Autoleucel
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   68/68 (100.00%)   14/14 (100.00%) 
Blood and lymphatic system disorders       
Anaemia † 1  10/10 (100.00%)  46/68 (67.65%)  7/14 (50.00%) 
Disseminated intravascular coagulation † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Febrile neutropenia † 1  0/10 (0.00%)  5/68 (7.35%)  0/14 (0.00%) 
Leukopenia † 1  0/10 (0.00%)  9/68 (13.24%)  4/14 (28.57%) 
Lymphopenia † 1  0/10 (0.00%)  6/68 (8.82%)  0/14 (0.00%) 
Neutropenia † 1  0/10 (0.00%)  25/68 (36.76%)  5/14 (35.71%) 
Thrombocytopenia † 1  0/10 (0.00%)  15/68 (22.06%)  3/14 (21.43%) 
Cardiac disorders       
Atrial fibrillation † 1  3/10 (30.00%)  4/68 (5.88%)  1/14 (7.14%) 
Bradycardia † 1  1/10 (10.00%)  5/68 (7.35%)  1/14 (7.14%) 
Cardiac flutter † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Palpitations † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Sinus bradycardia † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Sinus tachycardia † 1  4/10 (40.00%)  9/68 (13.24%)  2/14 (14.29%) 
Tachycardia † 1  0/10 (0.00%)  19/68 (27.94%)  5/14 (35.71%) 
Ventricular arrhythmia † 1  0/10 (0.00%)  2/68 (2.94%)  1/14 (7.14%) 
Ear and labyrinth disorders       
Deafness † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Ear pain † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Hypoacusis † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Eye disorders       
Conjunctival hyperaemia † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Papilloedema † 1  2/10 (20.00%)  1/68 (1.47%)  0/14 (0.00%) 
Vision blurred † 1  1/10 (10.00%)  4/68 (5.88%)  2/14 (14.29%) 
Gastrointestinal disorders       
Abdominal distension † 1  2/10 (20.00%)  3/68 (4.41%)  2/14 (14.29%) 
Abdominal pain † 1  2/10 (20.00%)  6/68 (8.82%)  2/14 (14.29%) 
Abdominal pain upper † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Abdominal tenderness † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Anorectal discomfort † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Constipation † 1  2/10 (20.00%)  20/68 (29.41%)  4/14 (28.57%) 
Diarrhoea † 1  5/10 (50.00%)  18/68 (26.47%)  5/14 (35.71%) 
Dry mouth † 1  3/10 (30.00%)  4/68 (5.88%)  2/14 (14.29%) 
Dyspepsia † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Dysphagia † 1  1/10 (10.00%)  5/68 (7.35%)  2/14 (14.29%) 
Flatulence † 1  1/10 (10.00%)  0/68 (0.00%)  1/14 (7.14%) 
Gastrooesophageal reflux disease † 1  1/10 (10.00%)  1/68 (1.47%)  1/14 (7.14%) 
Ileus † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Lip pain † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Mouth ulceration † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Nausea † 1  4/10 (40.00%)  22/68 (32.35%)  7/14 (50.00%) 
Oral mucosal erythema † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Oral pain † 1  2/10 (20.00%)  4/68 (5.88%)  0/14 (0.00%) 
Paraesthesia oral † 1  1/10 (10.00%)  1/68 (1.47%)  0/14 (0.00%) 
Retching † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Stomatitis † 1  2/10 (20.00%)  2/68 (2.94%)  1/14 (7.14%) 
Toothache † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Vomiting † 1  2/10 (20.00%)  7/68 (10.29%)  2/14 (14.29%) 
General disorders       
Congestion † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Asthenia † 1  3/10 (30.00%)  13/68 (19.12%)  2/14 (14.29%) 
Chest pain † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Chills † 1  7/10 (70.00%)  27/68 (39.71%)  6/14 (42.86%) 
Face oedema † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Facial pain † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Fatigue † 1  7/10 (70.00%)  24/68 (35.29%)  7/14 (50.00%) 
Gait disturbance † 1  1/10 (10.00%)  5/68 (7.35%)  0/14 (0.00%) 
Generalised oedema † 1  1/10 (10.00%)  2/68 (2.94%)  2/14 (14.29%) 
Malaise † 1  1/10 (10.00%)  4/68 (5.88%)  3/14 (21.43%) 
Non-cardiac chest pain † 1  1/10 (10.00%)  3/68 (4.41%)  1/14 (7.14%) 
Oedema † 1  1/10 (10.00%)  4/68 (5.88%)  0/14 (0.00%) 
Oedema peripheral † 1  1/10 (10.00%)  15/68 (22.06%)  5/14 (35.71%) 
Pain † 1  0/10 (0.00%)  5/68 (7.35%)  1/14 (7.14%) 
Pyrexia † 1  9/10 (90.00%)  59/68 (86.76%)  12/14 (85.71%) 
Immune system disorders       
Hypogammaglobulinaemia † 1  1/10 (10.00%)  10/68 (14.71%)  0/14 (0.00%) 
CYTOKINE RELEASE SYNDROME † 1  10/10 (100.00%)  62/68 (91.18%)  13/14 (92.86%) 
Infections and infestations       
Acute sinusitis † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Bacterial infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Candida infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Groin abscess † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Herpes zoster † 1  2/10 (20.00%)  3/68 (4.41%)  0/14 (0.00%) 
Influenza † 1  0/10 (0.00%)  3/68 (4.41%)  1/14 (7.14%) 
Metapneumovirus infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Oral candidiasis † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Oral infection † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Otitis externa † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Otitis media † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Pneumonia † 1  1/10 (10.00%)  4/68 (5.88%)  1/14 (7.14%) 
Sinusitis † 1  1/10 (10.00%)  5/68 (7.35%)  0/14 (0.00%) 
Tooth abscess † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Tooth infection † 1  1/10 (10.00%)  2/68 (2.94%)  0/14 (0.00%) 
Upper respiratory tract infection † 1  2/10 (20.00%)  9/68 (13.24%)  2/14 (14.29%) 
Urinary tract infection † 1  1/10 (10.00%)  2/68 (2.94%)  1/14 (7.14%) 
Viral infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Wound infection † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Skin Infection (BILATERAL HANDS, IMPETIGO) † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Injury, poisoning and procedural complications       
Fall † 1  1/10 (10.00%)  3/68 (4.41%)  0/14 (0.00%) 
Transfusion reaction † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Investigations       
Alanine aminotransferase increased † 1  3/10 (30.00%)  21/68 (30.88%)  2/14 (14.29%) 
Aspartate aminotransferase increased † 1  3/10 (30.00%)  14/68 (20.59%)  2/14 (14.29%) 
Blood alkaline phosphatase increased † 1  1/10 (10.00%)  8/68 (11.76%)  1/14 (7.14%) 
Blood bilirubin increased † 1  0/10 (0.00%)  7/68 (10.29%)  0/14 (0.00%) 
Blood creatinine increased † 1  1/10 (10.00%)  8/68 (11.76%)  2/14 (14.29%) 
Blood fibrinogen decreased † 1  1/10 (10.00%)  2/68 (2.94%)  0/14 (0.00%) 
Blood lactate dehydrogenase increased † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Blood phosphorus increased † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
C-reactive protein increased † 1  0/10 (0.00%)  1/68 (1.47%)  3/14 (21.43%) 
International normalised ratio increased † 1  0/10 (0.00%)  5/68 (7.35%)  0/14 (0.00%) 
Lymphocyte count decreased † 1  3/10 (30.00%)  8/68 (11.76%)  3/14 (21.43%) 
Neutrophil count decreased † 1  8/10 (80.00%)  35/68 (51.47%)  6/14 (42.86%) 
Past-pointing † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Platelet count decreased † 1  10/10 (100.00%)  36/68 (52.94%)  5/14 (35.71%) 
Respiratory rate increased † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Serum ferritin increased † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Troponin increased † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Weight decreased † 1  5/10 (50.00%)  2/68 (2.94%)  2/14 (14.29%) 
Weight increased † 1  0/10 (0.00%)  5/68 (7.35%)  1/14 (7.14%) 
White blood cell count decreased † 1  8/10 (80.00%)  27/68 (39.71%)  7/14 (50.00%) 
Metabolism and nutrition disorders       
Abnormal loss of weight † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Decreased appetite † 1  4/10 (40.00%)  14/68 (20.59%)  7/14 (50.00%) 
Dehydration † 1  1/10 (10.00%)  4/68 (5.88%)  0/14 (0.00%) 
Hyperglycaemia † 1  2/10 (20.00%)  14/68 (20.59%)  4/14 (28.57%) 
Hyperkalaemia † 1  1/10 (10.00%)  4/68 (5.88%)  1/14 (7.14%) 
Hypermagnesaemia † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Hypernatraemia † 1  0/10 (0.00%)  3/68 (4.41%)  1/14 (7.14%) 
Hypervolaemia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Hypoalbuminaemia † 1  5/10 (50.00%)  23/68 (33.82%)  4/14 (28.57%) 
Hypocalcaemia † 1  4/10 (40.00%)  19/68 (27.94%)  4/14 (28.57%) 
Hypoglycaemia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Hypokalaemia † 1  6/10 (60.00%)  21/68 (30.88%)  5/14 (35.71%) 
Hypomagnesaemia † 1  1/10 (10.00%)  10/68 (14.71%)  4/14 (28.57%) 
Hyponatraemia † 1  6/10 (60.00%)  22/68 (32.35%)  4/14 (28.57%) 
Hypophosphataemia † 1  4/10 (40.00%)  25/68 (36.76%)  4/14 (28.57%) 
Lactic acidosis † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  1/10 (10.00%)  6/68 (8.82%)  2/14 (14.29%) 
Back pain † 1  2/10 (20.00%)  8/68 (11.76%)  2/14 (14.29%) 
Bone pain † 1  2/10 (20.00%)  1/68 (1.47%)  1/14 (7.14%) 
Flank pain † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Muscle atrophy † 1  1/10 (10.00%)  1/68 (1.47%)  0/14 (0.00%) 
Muscular weakness † 1  3/10 (30.00%)  9/68 (13.24%)  1/14 (7.14%) 
Musculoskeletal pain † 1  0/10 (0.00%)  1/68 (1.47%)  2/14 (14.29%) 
Myalgia † 1  3/10 (30.00%)  7/68 (10.29%)  2/14 (14.29%) 
Neck pain † 1  1/10 (10.00%)  3/68 (4.41%)  1/14 (7.14%) 
Pain in extremity † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Squamous cell carcinoma † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Nervous system disorders       
Amnesia † 1  2/10 (20.00%)  1/68 (1.47%)  0/14 (0.00%) 
Aphasia † 1  2/10 (20.00%)  9/68 (13.24%)  4/14 (28.57%) 
Cognitive disorder † 1  1/10 (10.00%)  1/68 (1.47%)  2/14 (14.29%) 
Disturbance in attention † 1  0/10 (0.00%)  5/68 (7.35%)  0/14 (0.00%) 
Dizziness † 1  3/10 (30.00%)  9/68 (13.24%)  4/14 (28.57%) 
Dysarthria † 1  1/10 (10.00%)  2/68 (2.94%)  1/14 (7.14%) 
Dysgeusia † 1  0/10 (0.00%)  2/68 (2.94%)  1/14 (7.14%) 
Dysgraphia † 1  0/10 (0.00%)  0/68 (0.00%)  2/14 (14.29%) 
Dyskinesia † 1  1/10 (10.00%)  1/68 (1.47%)  0/14 (0.00%) 
Encephalopathy † 1  2/10 (20.00%)  14/68 (20.59%)  3/14 (21.43%) 
Facial paresis † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Headache † 1  7/10 (70.00%)  24/68 (35.29%)  5/14 (35.71%) 
Hemiparesis † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Hypoaesthesia † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Lethargy † 1  2/10 (20.00%)  5/68 (7.35%)  0/14 (0.00%) 
Memory impairment † 1  3/10 (30.00%)  5/68 (7.35%)  2/14 (14.29%) 
Migraine † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Neuralgia † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Neurological decompensation † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Neuropathy peripheral † 1  1/10 (10.00%)  6/68 (8.82%)  0/14 (0.00%) 
Neurotoxicity † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Nystagmus † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Paraesthesia † 1  2/10 (20.00%)  1/68 (1.47%)  3/14 (21.43%) 
Partial seizures † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Presyncope † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Restless legs syndrome † 1  1/10 (10.00%)  0/68 (0.00%)  1/14 (7.14%) 
Seizure † 1  1/10 (10.00%)  2/68 (2.94%)  0/14 (0.00%) 
Slow speech † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Somnolence † 1  1/10 (10.00%)  7/68 (10.29%)  1/14 (7.14%) 
Syncope † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Tremor † 1  3/10 (30.00%)  24/68 (35.29%)  7/14 (50.00%) 
Psychiatric disorders       
Agitation † 1  1/10 (10.00%)  5/68 (7.35%)  2/14 (14.29%) 
Anxiety † 1  4/10 (40.00%)  10/68 (14.71%)  3/14 (21.43%) 
Communication disorder † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Confusional state † 1  5/10 (50.00%)  13/68 (19.12%)  6/14 (42.86%) 
Depression † 1  0/10 (0.00%)  3/68 (4.41%)  1/14 (7.14%) 
Disorientation † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Insomnia † 1  3/10 (30.00%)  12/68 (17.65%)  5/14 (35.71%) 
Irritability † 1  1/10 (10.00%)  2/68 (2.94%)  1/14 (7.14%) 
Nervousness † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Psychotic disorder † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders       
Acute kidney injury † 1  1/10 (10.00%)  5/68 (7.35%)  1/14 (7.14%) 
Dysuria † 1  1/10 (10.00%)  2/68 (2.94%)  2/14 (14.29%) 
Nocturia † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Renal failure † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Urinary incontinence † 1  0/10 (0.00%)  2/68 (2.94%)  1/14 (7.14%) 
Urinary retention † 1  1/10 (10.00%)  8/68 (11.76%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Apnoea † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Cough † 1  3/10 (30.00%)  25/68 (36.76%)  5/14 (35.71%) 
Dysphonia † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Dyspnoea † 1  5/10 (50.00%)  13/68 (19.12%)  5/14 (35.71%) 
Dyspnoea exertional † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Hiccups † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Hypoxia † 1  4/10 (40.00%)  23/68 (33.82%)  7/14 (50.00%) 
Nasal congestion † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Oropharyngeal pain † 1  1/10 (10.00%)  5/68 (7.35%)  1/14 (7.14%) 
Pleural effusion † 1  3/10 (30.00%)  12/68 (17.65%)  5/14 (35.71%) 
Productive cough † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Pulmonary oedema † 1  0/10 (0.00%)  2/68 (2.94%)  1/14 (7.14%) 
Respiratory alkalosis † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Respiratory failure † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Respiratory tract congestion † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Tachypnoea † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Upper-airway cough syndrome † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Wheezing † 1  1/10 (10.00%)  2/68 (2.94%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders       
Alopecia † 1  1/10 (10.00%)  3/68 (4.41%)  1/14 (7.14%) 
Angioedema † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Dry skin † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Erythema † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Onychomadesis † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Pruritus † 1  0/10 (0.00%)  6/68 (8.82%)  1/14 (7.14%) 
Rash † 1  0/10 (0.00%)  9/68 (13.24%)  0/14 (0.00%) 
Rash erythematous † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Rash maculo-papular † 1  2/10 (20.00%)  5/68 (7.35%)  1/14 (7.14%) 
Rash pruritic † 1  1/10 (10.00%)  0/68 (0.00%)  0/14 (0.00%) 
Skin ulcer † 1  0/10 (0.00%)  1/68 (1.47%)  1/14 (7.14%) 
Swelling face † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Social circumstances       
Loss of personal independence in daily activities † 1  0/10 (0.00%)  0/68 (0.00%)  1/14 (7.14%) 
Vascular disorders       
Deep vein thrombosis † 1  0/10 (0.00%)  5/68 (7.35%)  1/14 (7.14%) 
Embolism † 1  0/10 (0.00%)  4/68 (5.88%)  0/14 (0.00%) 
Hypertension † 1  3/10 (30.00%)  13/68 (19.12%)  1/14 (7.14%) 
Hypotension † 1  2/10 (20.00%)  29/68 (42.65%)  10/14 (71.43%) 
Orthostatic hypotension † 1  1/10 (10.00%)  2/68 (2.94%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA 21.1 and 22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Kite, A Gilead Company
Phone: 844-454-5483(1-844-454-KITE)
EMail: medinfo@kitepharma.com
Publications of Results:
Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800.
Locke F, Wang M, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). American Society Of Clinical Oncology (ASCO) Annual Meeting 2016.
Wang M, Locke F, Siddiqi T, Castro J, Shah B, Lee H, et al. ZUMA-2: A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-C19 (Anti-CD19 CAR T cells) in Subjects with Relapsed/Refractory Mantle Cell Lymphoma (r/r MCL). European Society for Medical Oncology (ESMO) Congress 2016;Abstract 3305
Wang M, Locke FL, Munoz J, Goy A, Holmes HE, Siddiqi T, et al. ZUMA-2: Phase 2 Multicenter Study Evaluating Efficacy of Kte-C19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma [Abstract]. J Clin Oncol 2018;36 (Suppl 15):TPS3102.
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA, Miklos DB, Pagel JM, Kersten MJ, Milpied N, Fung H, Topp MS, Houot R, Beitinjaneh A, Peng W, Zheng L, Rossi JM, Jain RK, Rao AV, Reagan PM. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N Engl J Med. 2020 Apr 2;382(14):1331-1342. doi: 10.1056/NEJMoa1914347.
Wang, Michael; Rossi, John M.; Munoz, Javier; Goy, Andre; Lundry Locke, Frederick; Michael Reagan, Patrick; Jacobson, Caron A.; Hill, Brian T; Holmes, Houston; Mary Jaglowski, Samantha; Peng, Weimin; Zheng, Lianqing; Fang, Xiang; Xue, Allen; Rao, Arati V.; Bot, Adrian
Wang, Michael(1); Munoz, Javier(2); Goy, Andre(3); Locke, Frederick L.(4); Jacobson, Caron A.(5); Hill, Brian T.(6); Timmerman, John M.(7); Holmes, Houston(8); Jaglowski, Samantha(9); Flinn, Ian W.(10); McSweeney, Peter A.(11); Miklos, David B.(12); Pagel, John M.(13); José Kersten, Marie(14); Peng, Weimin(15); Zheng, Lianqing(15); Rossi, John M.(15); Jain, Rajul K.(15); Rao, Arati V.(15); Reagan, Patrick M.(16)
Wang, M.(1); Munoz, J.(2); Goy, A.(3); Locke, F.(4); Jacobson, C.(5); Hill, B.(6); Timmerman, J.(7); Holmes, H.(8); Jaglowski, S.(9); Flinn, I.(10); McSweeney, P.(11); Miklos, D.(12); Pagel, J.(13); Kersten, M. J.(14)(15)
Michael Wang,1 Javier Munoz,2 Andre Goy,3 Frederick L. Locke,4 Caron A. Jacobson,5 Brian T. Hill,6 John M. Timmerman,7 Houston Holmes,8 Samantha Jaglowski,9 Ian W. Flinn,10 Peter A. McSweeney,11 David B. Miklos,12 John M. Pagel,13 Marie José Kersten,14 Noel Milpied,15 Henry Fung,16 Max S. Topp,17 Roch Houot,18 Amer Beitinjaneh,19 Weimin Peng,20 Lianqing Zheng,20 John M. Rossi,20 Rajul K. Jain,20 Arati V. Rao,20 and Patrick M. Reagan21
Wang M, Munoz J, Goy A, Locke FL, Jacobson CA, Hill BT, Timmerman JM, Holmes H, Jaglowski S, Flinn IW, McSweeney PA,Miklos DB, Pagel JM, Kersten MJ, Peng W,Zheng L,Rossi JM, Jain RK, Rao AV, Reagan PM
Wang, Michael L., MD(1); Munoz, Javier, MD(2); Goy, Andre, MD(3); Locke, Frederick L., MD(4); Jacobson, Caron A., MD, MMSc(5); Hill, Brian T., MD(6); Timmerman, John M., MD(7); Holmes, Houston, MD(8); Jaglowski, Samantha, MD, MPH(9); Flinn, Ian W., MD, PhD(10); McSweeney, Peter A., MD(11); Miklos, David B., MD, PhD(12); Pagel, John M., MD, PhD, DSc(13); Jose Kersten, Marie, MD, PhD(14); Peng, Weimin, MS(15); Zheng, Lianqing, PhD(15); Rossi, John M., MS(15); Jain, Rajul K., MD(15); Rao, Arati V., MD(15); Reagan, Patrick M, MD(16)
Wang, Michael; Lundry Locke, Frederick; Munoz, Javier; Goy, Andre; Eccleston Holmes, Houston; Siddiqi, Tanya; Flinn, Ian; McSweeney, Peter A; Michael Reagan, Patrick; Thomas Hill, Brian; Jacobson, Caron A.; Rizzieri, David A.; Heffner, Leonard T.; Mary Jaglowski, Samantha; Bernard Miklos, David; Shaughnessy, Paul; Unabia, Sherry; Rossi, John M.; Jiang, Yizhou; Jain, Rajul K.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences ( Kite, A Gilead Company )
ClinicalTrials.gov Identifier: NCT02601313    
Other Study ID Numbers: KTE-C19-102
2015-005008-27 ( EudraCT Number )
2023-506641-35 ( Other Identifier: European Medicines Agency )
First Submitted: November 6, 2015
First Posted: November 10, 2015
Results First Submitted: August 21, 2020
Results First Posted: September 10, 2020
Last Update Posted: February 12, 2024