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NCT04074746 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      45
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Phase II_ Cohort 3(1x10^8/kg)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          39
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          40
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          35
        5. group Id
          BG004
          value
          45
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      3
    2. group Id
      BG001
      value
      3
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      35
    5. group Id
      BG004
      value
      45
    units
    Participants
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
    BG000
    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
    BG001
    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
    BG002
    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
    BG003
    title
    Phase II_ Cohort 3(1x10^8/kg)
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          31
        5. group Id
          BG004
          value
          39
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          6
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          12
        5. group Id
          BG004
          value
          15
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          23
        5. group Id
          BG004
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          5
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          33
        5. group Id
          BG004
          value
          40
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          35
        5. group Id
          BG004
          value
          45
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants

Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0

Preserved source evidence · Not medical advice