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NCT05883449 · FLOW

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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.

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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    title
    Safety run-in Cohort 4
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The three experimental Arms/Groups: 'Dose Level A in Hodgin Lymphoma', 'Dose Level B in Hodgin Lymphoma' and 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL' were not enrolled due to the decision to terminate this study earlier, which was based solely on the financial situation of the company and was not related to the safety or efficacy.
Complete source fields
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
    FG000
    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
    FG001
    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
    FG002
    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
    FG003
    title
    Safety run-in Cohort 4
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        7
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        6
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        3
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      2. group Id
        FG001
        num Subjects
        4
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
The three experimental Arms/Groups: 'Dose Level A in Hodgin Lymphoma', 'Dose Level B in Hodgin Lymphoma' and 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL' were not enrolled due to the decision to terminate this study earlier, which was based solely on the financial situation of the company and was not related to the safety or efficacy.

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Preserved source evidence · Not medical advice