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NCT05883449 · OUTCOME

Duration of Response 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
Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)

What was measured

Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee.

Analysis population: All patients in the Safety Run In Set who had a response (CR or PR) assessed by the independent review committee.

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 15
Safety run-in Cohort 25
Safety run-in Cohort 36
Safety run-in Cohort 45

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Safety run-in Cohort 14.90Not reported2.20NANot enough events to calculate the data
Safety run-in Cohort 2NANot reportedNANANot enough events to calculate the data
Safety run-in Cohort 3NANot reportedNANANot enough events to calculate the data
Safety run-in Cohort 46.97Not reported2.30NANot 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
        2.20
        upper Limit
        NA
        value
        4.90
      2. comment
        Not enough events to calculate the data
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      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
        2.30
        upper Limit
        NA
        value
        6.97
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      5
    units
    Participants
description
Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee.
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
All patients in the Safety Run In Set who had a response (CR or PR) assessed by the independent review committee.
reporting Status
POSTED
time Frame
Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)
title
Duration of Response by Independent Radiology Committee
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice