Trial Outcomes & Findings for AFM13 in Relapsed/Refractory Cutaneous Lymphomas (NCT NCT03192202)
NCT ID: NCT03192202
Last Updated: 2023-07-20
Results Overview
Incidence of Treatment-Emergent Adverse Events \[Safety and Toxicity\] broken down by adverse event and CTCAE v4.0 grade of each event.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2023-07-20
Participant Flow
Participant milestones
| Measure |
Cohort 1
1.5 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 2
7.0 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 3
7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 4
200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AFM13 in Relapsed/Refractory Cutaneous Lymphomas
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
1.5 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 2
n=3 Participants
7.0 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 3
n=3 Participants
7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 4
n=6 Participants
200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
15 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsIncidence of Treatment-Emergent Adverse Events \[Safety and Toxicity\] broken down by adverse event and CTCAE v4.0 grade of each event.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1.5 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 2
n=3 Participants
7.0 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 3
n=3 Participants
7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 4
n=6 Participants
200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
G3/4 Infection and skin rash
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
G1 IRR
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Death, G3 infection , IRR
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
No AE
|
2 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsThe sum of patients with partial responses and complete responses.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1.5 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 2
n=3 Participants
7.0 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 3
n=3 Participants
7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 4
n=6 Participants
200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
1.5 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 2
n=3 participants at risk
7.0 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 3
n=3 participants at risk
7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 4
n=6 participants at risk
200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
G3/4 Infection and skin rash
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
G1 IRR
|
0.00%
0/3 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
|
General disorders
Death, G3 infection, IRR
|
0.00%
0/3 • 2 years
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
1.5 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 2
n=3 participants at risk
7.0 mg/kg of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 3
n=3 participants at risk
7.0 mg/kg CIVI of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
Cohort 4
n=6 participants at risk
200 mg ( Flat dose) of AFM13 once weekly for weeks 1-8.
AFM13: AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
|
|---|---|---|---|---|
|
General disorders
Infusion related reaction (IRR)
|
0.00%
0/3 • 2 years
|
100.0%
3/3 • Number of events 12 • 2 years
|
0.00%
0/3 • 2 years
|
0.00%
0/6 • 2 years
|
Additional Information
Ahmed Sawas, MD
Columbia University Irving Medical Center (CUIMC)
Phone: 212-305-0591
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place