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NCT03277729 · BASELINE

Baseline characteristics

A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas · Source last updated 2026-06-22

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
      1
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      31
    6. group Id
      BG005
      value
      50
    units
    Participants
groups
  1. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG000
    title
    Dose Level 0 of CD20 CAR T Cells
  2. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG001
    title
    Dose Level 1 of CD20 CAR T Cells
  3. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG002
    title
    Dose Level 2 of CD20 CAR T Cells
  4. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG003
    title
    Dose Level 3 of CD20 CAR-T Cells
  5. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG004
    title
    Dose Level 4 of CD20 CAR-T Cells
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0
          value
          43
        2. group Id
          BG001
          spread
          9
          value
          61
        3. group Id
          BG002
          spread
          8
          value
          61
        4. group Id
          BG003
          spread
          9
          value
          59
        5. group Id
          BG004
          spread
          8
          value
          67
        6. group Id
          BG005
          spread
          9
          value
          64
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          31
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          46
        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
          2
        6. group Id
          BG005
          value
          2
        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
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          50
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Patients enrolled and treated on study.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      1
    2. group Id
      BG001
      value
      8
    3. group Id
      BG002
      value
      4
    4. group Id
      BG003
      value
      6
    5. group Id
      BG004
      value
      31
    6. group Id
      BG005
      value
      50
    units
    Participants
groups
  1. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 1 contains patients treated at Dose Level 0 (1 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^4 - 2.80 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG000
    title
    Dose Level 0 of CD20 CAR T Cells
  2. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 2 contains patients treated at Dose Level 1 (3.3 x 10\^5 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^5 - 8.50 x 10\^5 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG001
    title
    Dose Level 1 of CD20 CAR T Cells
  3. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 3 contains patients treated at Dose Level 2 (1 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 8.51 x 10\^5 - 2.80 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG002
    title
    Dose Level 2 of CD20 CAR T Cells
  4. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 4 contains patients treated at Dose Level 3 (3.3 x 10\^6 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: 2.81 x 10\^6 - 8.50 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG003
    title
    Dose Level 3 of CD20 CAR-T Cells
  5. description
    Patients undergo leukapheresis and may receive treatment after if needed for disease control. Patients then receive cyclophosphamide IV. Patients may also receive fludarabine IV. After 36-96 hours, patients receive CD20-specific CAR T cell infusion IV over 20-30 minutes. Arm 5 contains patients treated at Dose Level 4 (1 x 10\^7 tCD19+ T cells/kg, CAR T Cell Dose Inclusion Range: \> 8.5 x 10\^6 tCD19+ T cells/kg) Chimeric Antigen Receptor T Cell Therapy: CD20 CAR T cell IV Leukapheresis: Undergo leukapheresis Cyclophosphamide: Given IV Fludarabine Phosphate: Given IV
    id
    BG004
    title
    Dose Level 4 of CD20 CAR-T Cells
  6. description
    Total of all reporting groups
    id
    BG005
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          0
          value
          43
        2. group Id
          BG001
          spread
          9
          value
          61
        3. group Id
          BG002
          spread
          8
          value
          61
        4. group Id
          BG003
          spread
          9
          value
          59
        5. group Id
          BG004
          spread
          8
          value
          67
        6. group Id
          BG005
          spread
          9
          value
          64
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          2
        5. group Id
          BG004
          value
          13
        6. group Id
          BG005
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          6
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          4
        5. group Id
          BG004
          value
          18
        6. group Id
          BG005
          value
          31
        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
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        5. group Id
          BG004
          value
          1
        6. group Id
          BG005
          value
          2
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          28
        6. group Id
          BG005
          value
          46
        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
          2
        6. group Id
          BG005
          value
          2
        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
          1
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          6
        5. group Id
          BG004
          value
          31
        6. group Id
          BG005
          value
          50
      title
      United States
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Patients enrolled and treated on study.

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

Preserved source evidence · Not medical advice