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NCT04074746 · FLOW

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Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas · Source last updated 2026-09-30

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

groups
  1. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG000
    title
    Phase I_ Cohort 1(1x10^6/kg)
  2. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG001
    title
    Phase I_ Cohort 2(1x10^7/kg
  3. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG002
    title
    Phase I_ Cohort 3(1x10^8/kg)
  4. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG003
    title
    Phase II_ Cohort 3(1x10^8/kg)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Infection
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        33
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG000
    title
    Phase I_ Cohort 1(1x10^6/kg)
  2. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG001
    title
    Phase I_ Cohort 2(1x10^7/kg
  3. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG002
    title
    Phase I_ Cohort 3(1x10^8/kg)
  4. description
    Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21. Anti-CD30/CD16A Monoclonal Antibody AFM13: Given IV Cyclophosphamide: Given IV Fludarabine: Given IV Fludarabine Phosphate: Given IV Genetically Engineered Lymphocyte Therapy: Given AFM13-NK cells IV
    id
    FG003
    title
    Phase II_ Cohort 3(1x10^8/kg)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        1
      type
      Infection
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        35
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        33
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice