Skip to content
Triangle logo TriangleGet started
← Full study record

NCT05537766 · BASELINE

Baseline characteristics

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies · Source last updated 2026-03-10

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
      0
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      10
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      15
    units
    Participants
groups
  1. description
    This substudy was withdrawn; therefore, no participants were enrolled.
    id
    BG000
    title
    Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
  2. description
    Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG001
    title
    Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
  3. description
    Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG002
    title
    Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
  4. description
    Participants with Relapsed/Refractory hairy cell leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG003
    title
    Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG001
          value
          2
        2. group Id
          BG002
          value
          8
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          11
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG001
          value
          2
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          4
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG001
          spread
          4.1
          value
          64
        2. group Id
          BG002
          spread
          12.7
          value
          52
        3. comment
          Standard deviation cannot be calculated for one participant.
          group Id
          BG003
          spread
          NA
          value
          63
        4. group Id
          BG004
          spread
          11.9
          value
          56
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          5
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG001
          value
          3
        2. group Id
          BG002
          value
          5
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          9
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          3
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG001
          value
          4
        2. group Id
          BG002
          value
          6
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          11
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG001
          value
          4
        2. group Id
          BG002
          value
          9
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          14
        title
        White
      6. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          3
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          4
      title
      Netherlands
    2. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          4
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          4
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG001
          value
          2
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          3
      title
      Italy
    4. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          2
      title
      Switzerland
    5. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
      title
      Germany
    6. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      0
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      10
    4. group Id
      BG003
      value
      1
    5. group Id
      BG004
      value
      15
    units
    Participants
groups
  1. description
    This substudy was withdrawn; therefore, no participants were enrolled.
    id
    BG000
    title
    Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel
  2. description
    Participants with Relapsed/Refractory Richter Transformation received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG001
    title
    Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel
  3. description
    Participants with Relapsed/Refractory Burkitt Lymphoma received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG002
    title
    Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel
  4. description
    Participants with Relapsed/Refractory hairy cell leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day IV and cyclophosphamide 500 mg/m\^2/day IV for 3 days (Day -5 to Day -3). A single IV infusion of brexucabtagene autoleucel at target dose of 2 × 10\^6 anti-CD19 CAR T cells/kg on Day 0.
    id
    BG003
    title
    Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
  5. description
    Total of all reporting groups
    id
    BG004
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG001
          value
          2
        2. group Id
          BG002
          value
          8
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          11
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG001
          value
          2
        2. group Id
          BG002
          value
          2
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          4
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG001
          spread
          4.1
          value
          64
        2. group Id
          BG002
          spread
          12.7
          value
          52
        3. comment
          Standard deviation cannot be calculated for one participant.
          group Id
          BG003
          spread
          NA
          value
          63
        4. group Id
          BG004
          spread
          11.9
          value
          56
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          5
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          6
        title
        Female
      2. measurements
        1. group Id
          BG001
          value
          3
        2. group Id
          BG002
          value
          5
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          9
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          3
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG001
          value
          4
        2. group Id
          BG002
          value
          6
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          11
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  5. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG001
          value
          4
        2. group Id
          BG002
          value
          9
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          14
        title
        White
      6. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
        title
        More than one race
      7. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          0
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  6. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          3
        3. group Id
          BG003
          value
          1
        4. group Id
          BG004
          value
          4
      title
      Netherlands
    2. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          4
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          4
      title
      United States
    3. categories
      1. measurements
        1. group Id
          BG001
          value
          2
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          3
      title
      Italy
    4. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          2
      title
      Switzerland
    5. categories
      1. measurements
        1. group Id
          BG001
          value
          1
        2. group Id
          BG002
          value
          0
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
      title
      Germany
    6. categories
      1. measurements
        1. group Id
          BG001
          value
          0
        2. group Id
          BG002
          value
          1
        3. group Id
          BG003
          value
          0
        4. group Id
          BG004
          value
          1
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
population Description
The Safety Analysis Set included all participants who took at least 1 dose of study drug.

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

Preserved source evidence · Not medical advice