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NCT05883449 · OUTCOME

Progression-free Survival (PFS) 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the first treatment received until the first progression disease assessed by IRC or death.

What was measured

Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment.

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

GroupSource count
Safety run-in Cohort 16
Safety run-in Cohort 26
Safety run-in Cohort 36
Safety run-in Cohort 46

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety run-in Cohort 14.17Not reported1.45NANot enough events to calculate the data.
Safety run-in Cohort 27.66Not reported1.28NANot enough events to calculate the data.
Safety run-in Cohort 3NANot reportedNANANot enough events to calculate the data.
Safety run-in Cohort 48.28Not reported1.35NANot enough events to calculate the data.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not enough events to calculate the data.
        group Id
        OG000
        lower Limit
        1.45
        upper Limit
        NA
        value
        4.17
      2. comment
        Not enough events to calculate the data.
        group Id
        OG001
        lower Limit
        1.28
        upper Limit
        NA
        value
        7.66
      3. comment
        Not enough events to calculate the data.
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      4. comment
        Not enough events to calculate the data.
        group Id
        OG003
        lower Limit
        1.35
        upper Limit
        NA
        value
        8.28
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    units
    Participants
description
Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment.
dispersion Type
95% Confidence Interval
groups
  1. 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
  2. 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
  3. 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
  4. 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
MEDIAN
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
From the first treatment received until the first progression disease assessed by IRC or death.
title
Progression-free Survival (PFS) by Independent Radiology Committee
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice