NCT04074746 · ADVERSE EVENTS

Adverse events

Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas · Source last updated 2026-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: 1 year
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Phase I_ Cohort 1(1x10^6/kg) Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV	0 / 3	2 / 3	2 / 3
Phase I_ Cohort 2(1x10^7/kg) Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV	0 / 3	3 / 3	2 / 3
Phase I_ Cohort 3(1x10^8/kg) Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV	0 / 4	1 / 4	2 / 4
Phase II_ Cohort 3(1x10^8/kg) Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV	0 / 35	9 / 35	14 / 35

Group identifiers: EG000: Phase I_ Cohort 1(1x10^6/kg) · EG001: Phase I_ Cohort 2(1x10^7/kg) · EG002: Phase I_ Cohort 3(1x10^8/kg) · EG003: Phase II_ Cohort 3(1x10^8/kg)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
3
num At Risk
3
num Events
5
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
5
num At Risk
35
num Events
8
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
3
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
2
num At Risk
35
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
35
num Events
1
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
3
num At Risk
35
num Events
3
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
9
num At Risk
35
num Events
17
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Flank pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
35
num Events
1
term
White blood cell decreased

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
3
description
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
id
EG000
other Num Affected
2
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I_ Cohort 1(1x10^6/kg)
deaths Num Affected
2
deaths Num At Risk
3
description
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
id
EG001
other Num Affected
3
other Num At Risk
3
serious Num Affected
0
serious Num At Risk
3
title
Phase I_ Cohort 2(1x10^7/kg)
deaths Num Affected
2
deaths Num At Risk
4
description
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
id
EG002
other Num Affected
1
other Num At Risk
4
serious Num Affected
0
serious Num At Risk
4
title
Phase I_ Cohort 3(1x10^8/kg)
deaths Num Affected
14
deaths Num At Risk
35
description
Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
id
EG003
other Num Affected
9
other Num At Risk
35
serious Num Affected
0
serious Num At Risk
35
title
Phase II_ Cohort 3(1x10^8/kg)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
3
num At Risk
3
num Events
5
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
5
num At Risk
35
num Events
8
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
1
group Id
EG001
num Affected
2
num At Risk
3
num Events
3
group Id
EG002
num Affected
1
num At Risk
4
num Events
1
group Id
EG003
num Affected
2
num At Risk
35
num Events
2
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
35
num Events
1
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Headache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
3
num At Risk
35
num Events
3
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
9
num At Risk
35
num Events
17
term
Infusion related reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
3
num Events
2
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Pruritus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Flank pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
1
num At Risk
3
num Events
1
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
0
num At Risk
35
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
0
num At Risk
3
num Events
0
group Id
EG001
num Affected
0
num At Risk
3
num Events
0
group Id
EG002
num Affected
0
num At Risk
4
num Events
0
group Id
EG003
num Affected
1
num At Risk
35
num Events
1
term
White blood cell decreased

time Frame

1 year

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Preserved source evidence · Not medical advice