NCT05883449 · OUTCOME

Objective Response Rate (ORR) by Independent Radiology Committee

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: Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.

What was measured

Best ORR (complete response (CR) + partial response \[PR\]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.

Analysis population: The Safety Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.

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	6
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	5	Not reported	Not reported	Not reported	Not reported
Safety run-in Cohort 3	6	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
5
group Id
OG002
value
6
group Id
OG003
value
5

denoms

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

description

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 Run In Set (SRI) consists of all subjects of the 4 safety run-in cohorts who have received at least 66% of the combination dose during Cycle 1.

reporting Status

POSTED

time Frame

Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.

title

Objective Response Rate (ORR) by Independent Radiology Committee

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice