NCT05883449 · OUTCOME

Frequency of Subjects With Study Drug Related TEAEs

Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL · Source last updated 2025-08-20

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)

What was measured

The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs)

Analysis population: The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.

Groups in this outcome

Safety run-in Cohort 1

Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously

Safety run-in Cohort 2

Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously

Safety run-in Cohort 3

Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously

Safety run-in Cohort 4

Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Safety run-in Cohort 1	6
Safety run-in Cohort 2	7
Safety run-in Cohort 3	6
Safety run-in Cohort 4	6

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Safety run-in Cohort 1	5	Not reported	Not reported	Not reported	Not reported
Safety run-in Cohort 2	4	Not reported	Not reported	Not reported	Not reported
Safety run-in Cohort 3	5	Not reported	Not reported	Not reported	Not reported
Safety run-in Cohort 4	5	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4
group Id
OG002
value
5
group Id
OG003
value
5

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
7
group Id
OG002
value
6
group Id
OG003
value
6
units
Participants

description

The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs)

groups

description
Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously
id
OG000
title
Safety run-in Cohort 1
description
Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously
id
OG001
title
Safety run-in Cohort 2
description
Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously
id
OG002
title
Safety run-in Cohort 3
description
Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) AFM13: anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion AB-101: NK cell therapy, intravenous infusion Cyclophosphamide: Lymphodepleting chemotherapy, intravenous infusion Fludarabine: Lymphodepleting chemotherapy, intravenous infusion Interleukin-2: Immune cytokine, subcutaneously
id
OG003
title
Safety run-in Cohort 4

param Type

COUNT_OF_PARTICIPANTS

population Description

The safety analysis set (SAS) will consist of all subjects who received any amount of any component of the regimen.

reporting Status

POSTED

time Frame

From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)

title

Frequency of Subjects With Study Drug Related TEAEs

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice