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Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides (REDIRECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101331
Recruitment Status : Completed
First Posted : September 24, 2019
Results First Posted : June 5, 2023
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Affimed GmbH

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Peripheral T Cell Lymphoma
Transformed Mycosis Fungoides
Intervention Drug: AFM13
Enrollment 108
Recruitment Details This study was a Phase II open-label multicenter study to assess the efficacy and safety of AFM13 in subjects with relapsed or refractory CD30-positive peripheral T-cell lymphoma.
Pre-assignment Details All the subjects were screened for CD30 expression. Investigators assessed the subjects, and they were enrolled in the study if they met all inclusion criteria and none of the exclusion criteria.
Arm/Group Title Cohort A
Hide Arm/Group Description Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Period Title: Overall Study
Started 108
Completed [1] 8
Not Completed 100
Reason Not Completed
Adverse Event             7
Disease progression             79
Withdrawal by Subject             1
Investigator decision             6
Death             6
Allogenic transplant             1
[1]
'Completed' are subjects still on treatment at the time of interim analysis.
Arm/Group Title Cohort A
Hide Arm/Group Description Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Baseline Participants 108
Hide Baseline Analysis Population Description
Full analysis set (FAS): consist of all subjects who received at least one dose of AFM13.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
61.1  (13.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
42
  38.9%
Male
66
  61.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Hispanic or Latino
5
   4.6%
Not Hispanic or Latino
90
  83.3%
Unknown or Not Reported
13
  12.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
American Indian or Alaska Native
0
   0.0%
Asian
15
  13.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   4.6%
White
75
  69.4%
More than one race
0
   0.0%
Unknown or Not Reported
13
  12.0%
1.Primary Outcome
Title Overall Response Rate Assessed by Independent Review Committee Based on PET-CT
Hide Description Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
32.4
(23.7 to 42.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments One-sided p-value.
Method Exact binomial test
Comments Exact binomial test compares versus a proportion of 0.25.
2.Secondary Outcome
Title Overall Response Rate Assessed by Investigator Based on PET-CT
Hide Description Overall response by Positron Emission Tomography-Computed Tomography (PET-CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
31.5
(22.9 to 41.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.077
Comments One-sided p-value.
Method Exact binomial test
Comments Exact binomial test compares versus a proportion of 0.25.
3.Secondary Outcome
Title Overall Response Rate Assessed by Investigator Based on CT
Hide Description Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by the investigator utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
29.6
(21.2 to 39.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.159
Comments One-sided p-value.
Method Exact binomial test
Comments Exact binomial test compares versus a proportion of 0.25.
4.Secondary Outcome
Title Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT
Hide Description Complete response and/or partial response by Positron Emission Tomography-Computed Tomography (PET-CT) assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
Complete response rate (CR rate)
10.2
(5.2 to 17.5)
Partial response rate (PR rate)
22.2
(14.8 to 31.2)
5.Secondary Outcome
Title Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT
Hide Description Overall response by Computed Tomography (CT) as defined by achieving complete response and/or partial response assessed by an Independent Review Committee (IRC) utilizing the modified Lugano Classification Revised Staging System for malignant lymphoma (Cheson, 2014).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage
Overall response rate (ORR)
24.1
(16.4 to 33.3)
Complete response rate (CR rate)
8.3
(3.9 to 15.2)
Partial response rate (PR rate)
15.7
(9.4 to 24.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cohort A
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.537
Comments One-sided p-value.
Method Exact binomial test
Comments Exact binomial test compares versus a proportion of 0.25.
6.Secondary Outcome
Title Duration of Overall Response Assessed by Independent Review Committee Based on PET-CT
Hide Description Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by Independent Review Committee (IRC).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 26 months).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects of the full analysis set (FAS) who had a response in PET assessed by IRC.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 35
Median (95% Confidence Interval)
Unit of Measure: months
2.3
(1.9 to 6.5)
7.Secondary Outcome
Title Duration of Overall Response Assessed by Independent Review Committee Based on CT
Hide Description Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by Independent Review Committee (IRC).
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 26 months).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects of the full analysis set (FAS) who had a response in CT assessed by IRC.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 26
Median (95% Confidence Interval)
Unit of Measure: months
2.1
(1.9 to 7.4)
8.Secondary Outcome
Title Duration of Overall Response Assessed by Investigator Based on PET-CT
Hide Description Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Positron Emission Tomography-Computed Tomography (PET-CT) by the investigator.
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 26 months).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects of the full analysis set (FAS) who had a response in PET-CT assessed by investigator.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 34
Median (95% Confidence Interval)
Unit of Measure: months
2.2
(1.9 to 9.0)
9.Secondary Outcome
Title Duration of Overall Response Assessed by Investigator Based on CT
Hide Description Duration of response (DOR) defined as the period from first Partial Response (PR) and Complete Response (CR) assessment till first assessment of progressive disease or death. Response assessed by Computed Tomography (CT) by the investigator.
Time Frame Tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 26 months).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects of the full analysis set (FAS) who had a response in CT assessed by investigator.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 32
Median (95% Confidence Interval)
Unit of Measure: months
5.9
(1.9 to 9.0)
10.Secondary Outcome
Title Number of Subjects With Treatment Related Adverse Event
Hide Description Number of subjects who had treatment (AFM13) related Adverse Events.
Time Frame From the date of first treatment until the date of the last treatment + 37 days, up to 138 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Count of Participants
Unit of Measure: Participants
79
  73.1%
11.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of AFM13
Hide Description Maximum measured concentration (Cmax) of the AFM13 in plasma.
Time Frame Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 20
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Nanogram/milliliter
Cycle 1 - day 1 Number Analyzed 20 participants
26232
(270%)
Cycle 1 - day 29 Number Analyzed 16 participants
24435
(364%)
12.Secondary Outcome
Title Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)
Hide Description Area under concentration (AUC) versus time curve of the AFM13 in plasma over time interval from 0 extrapolated to infinity.
Time Frame Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram*hour/milliliter
Cycle 1 - day 1 Number Analyzed 18 participants
612361
(60.3%)
Cycle 1 - day 29 Number Analyzed 13 participants
749717
(35%)
13.Secondary Outcome
Title Volume of Distribution at Steady State (Vss) of AFM13
Hide Description Volume of distribution at steady state (Vss) of the AFM13.
Time Frame Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter
Cycle 1 - day 1 Number Analyzed 18 participants
7.46
(41.2%)
Cycle 1 - day 29 Number Analyzed 13 participants
5.1
(58.4%)
14.Secondary Outcome
Title The Terminal Half-life (t1/2) of AFM13
Hide Description The terminal half-life (t1/2) of the AFM13.
Time Frame Predose and 1 hour after start of infusion, end of injection (EOI) and 1 hour, 2 hours, 3 hours, 24 hours and 48 hours after EOI on Cycle 1 Day 1 and Day 29.
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic set (PK) consists of subjects who had at least received one dose of study drug and had at least one post dose PK measurement.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 18
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
Cycle 1 - day 1 Number Analyzed 18 participants
20.7
(35.9%)
Cycle 1 - day 29 Number Analyzed 13 participants
19.6
(47.4%)
15.Secondary Outcome
Title European Quality of Life 5-dimensional Pain/Discomfort Score (EQ-5D)
Hide Description Quality of Life (QoL) as measured by the European QoL 5-dimensional questionnaire (EQ-5D) for Cohorts A. The EQ-5D comprises asks for the current health state in the five dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Pain/discomfort scores assessed based on questionnaire. The categories of the response offer three levels pain/discomfort score: "no pain or discomfort" (score of 1), "moderate pain or discomfort" (score of 2), and "extreme pain and discomfort" (score of 3). Scores are presented from baseline to each visit for Cohort A.
Time Frame At baseline and final study visit, up to 138 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline No pain or discomfort
41
  38.0%
Moderate pain or discomfort
55
  50.9%
Extreme pain or discomfort
9
   8.3%
Missing
3
   2.8%
Final Study Visit No pain or discomfort
17
  15.7%
Moderate pain or discomfort
36
  33.3%
Extreme pain or discomfort
4
   3.7%
Missing
51
  47.2%
16.Secondary Outcome
Title European Quality of Life 5-dimensional Visual Analogue Scale Scores (EQ-5D)
Hide Description Quality of Life (QoL) as measured by the European Quality of Life 5-dimensional questionnaire (EQ-5D) for Cohorts A. Visual Analogue Scale scores assessed based on drawn scale from 0(worst imaginable state) to 100(best imaginable state). Subjects chose their health state on scale based on their situation by themselves.
Time Frame From baseline until final study visit, up to 138 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) followed the intent to treat (ITT) principle and consisted of all subjects who received at least one dose of AFM13.
Arm/Group Title Cohort A
Hide Arm/Group Description:
Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
Overall Number of Participants Analyzed 108
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.8  (23.36)
Time Frame From the date of first treatment till the date of the last treatment + 37 days, up to 138 weeks.
Adverse Event Reporting Description The safety set consisted of all subjects who received at least one dose of AFM13 and had at least one post-baseline safety assessment.
 
Arm/Group Title Cohort A
Hide Arm/Group Description Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).
All-Cause Mortality
Cohort A
Affected / at Risk (%)
Total   46/108 (42.59%) 
Hide Serious Adverse Events
Cohort A
Affected / at Risk (%)
Total   43/108 (39.81%) 
Blood and lymphatic system disorders   
Disseminated intravascular coagulation † 1  1/108 (0.93%) 
Cardiac disorders   
Acute left ventricular failure † 1  1/108 (0.93%) 
Cardiomyopathy † 1  1/108 (0.93%) 
General disorders   
Pyrexia † 1  2/108 (1.85%) 
Chills † 1  1/108 (0.93%) 
General physical health deterioration † 1  1/108 (0.93%) 
Pain † 1  1/108 (0.93%) 
Infections and infestations   
COVID-19 † 1  9/108 (8.33%) 
Pneumonia † 1  5/108 (4.63%) 
Herpes zoster † 1  2/108 (1.85%) 
Septic shock † 1  2/108 (1.85%) 
COVID-19 pneumonia † 1  1/108 (0.93%) 
Clostridium difficile colitis † 1  1/108 (0.93%) 
Cytomegalovirus infection reactivation † 1  1/108 (0.93%) 
Enterococcal bacteraemia † 1  1/108 (0.93%) 
Orchitis † 1  1/108 (0.93%) 
Periodontitis † 1  1/108 (0.93%) 
Pneumonia aspiration † 1  1/108 (0.93%) 
Respiratory tract infection † 1  1/108 (0.93%) 
Rhinovirus infection † 1  1/108 (0.93%) 
Soft tissue infection † 1  1/108 (0.93%) 
Staphylococcal sepsis † 1  1/108 (0.93%) 
Streptococcal bacteraemia † 1  1/108 (0.93%) 
Vascular access site infection † 1  1/108 (0.93%) 
Injury, poisoning and procedural complications   
Infusion related reaction † 1  5/108 (4.63%) 
Investigations   
Hepatic enzyme increased † 1  1/108 (0.93%) 
International normalised ratio increased † 1  1/108 (0.93%) 
Metabolism and nutrition disorders   
Dehydration † 1  1/108 (0.93%) 
Hyponatraemia † 1  1/108 (0.93%) 
Musculoskeletal and connective tissue disorders   
Back pain † 1  1/108 (0.93%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Cancer pain † 1  1/108 (0.93%) 
Diffuse large B-cell lymphoma † 1  1/108 (0.93%) 
Nervous system disorders   
Ischaemic cerebral infarction † 1  1/108 (0.93%) 
Renal and urinary disorders   
Acute kidney injury † 1  3/108 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome † 1  2/108 (1.85%) 
Dyspnoea † 1  1/108 (0.93%) 
Haemoptysis † 1  1/108 (0.93%) 
Pulmonary embolism † 1  1/108 (0.93%) 
Pulmonary haemorrhage † 1  1/108 (0.93%) 
Pulmonary oedema † 1  1/108 (0.93%) 
Vascular disorders   
Superior vena cava syndrome † 1  1/108 (0.93%) 
1
Term from vocabulary, MedDRA Version 25.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A
Affected / at Risk (%)
Total   95/108 (87.96%) 
Blood and lymphatic system disorders   
Anaemia † 1  16/108 (14.81%) 
Neutropenia † 1  14/108 (12.96%) 
Thrombocytopenia † 1  13/108 (12.04%) 
Lymphopenia † 1  6/108 (5.56%) 
Gastrointestinal disorders   
Constipation † 1  13/108 (12.04%) 
Diarrhoea † 1  12/108 (11.11%) 
Nausea † 1  11/108 (10.19%) 
Abdominal pain † 1  10/108 (9.26%) 
Vomiting † 1  8/108 (7.41%) 
Dyspepsia † 1  6/108 (5.56%) 
General disorders   
Pyrexia † 1  20/108 (18.52%) 
Asthenia † 1  9/108 (8.33%) 
Chills † 1  7/108 (6.48%) 
Infections and infestations   
Upper respiratory tract infection † 1  6/108 (5.56%) 
Injury, poisoning and procedural complications   
Infusion related reaction † 1  25/108 (23.15%) 
Investigations   
Blood lactate dehydrogenase increased † 1  6/108 (5.56%) 
Metabolism and nutrition disorders   
Hypokalaemia † 1  8/108 (7.41%) 
Decreased appetite † 1  7/108 (6.48%) 
Hypomagnesaemia † 1  7/108 (6.48%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  9/108 (8.33%) 
Nervous system disorders   
Headache † 1  10/108 (9.26%) 
Psychiatric disorders   
Insomnia † 1  8/108 (7.41%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  9/108 (8.33%) 
Dyspnoea † 1  8/108 (7.41%) 
Oropharyngeal pain † 1  8/108 (7.41%) 
Skin and subcutaneous tissue disorders   
Rash † 1  17/108 (15.74%) 
Erythema † 1  10/108 (9.26%) 
Pruritus † 1  7/108 (6.48%) 
1
Term from vocabulary, MedDRA Version 25.0
†
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.
The sponsor has the right to review communications for 90 days prior to public release (whereby the sponsor may ask to consider modifications to ensure necessary protection of sponsor's IP). Any publication shall be not made before the first multi-centre publication if the study is a part of a multi-centred clinical trial. Also, if a publication concerns the analyses of data from a multi-centred clinical trial, the communication shall make reference to the relevant multi-centre publication
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Operations
Organization: Affimed GmbH
Phone: +49 62216530770
EMail: trials@affimed.com
Layout table for additonal information
Responsible Party: Affimed GmbH
ClinicalTrials.gov Identifier: NCT04101331    
Other Study ID Numbers: AFM13-202
First Submitted: September 20, 2019
First Posted: September 24, 2019
Results First Submitted: May 8, 2023
Results First Posted: June 5, 2023
Last Update Posted: February 2, 2024