Participant flow

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.

groups

1. description

   This substudy was withdrawn; therefore, no participants were enrolled.

   id

   FG000

   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 intravenously (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-cluster of differentiation 19 (CD19) chimeric antigen receptor (CAR) T cells/kg on Day 0.

   id

   FG001

   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 intravenously (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

   FG002

   title

   Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel

4. description

   Participant with Relapsed/Refractory Hairy Cell Leukemia received the following treatment during the study: Lymphodepletion chemotherapy regimen of fludarabine 30 mg/m\^2/day intravenously (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

   FG003

   title

   Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      type

      Rolled Over or Consented to a LTFU Study

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   4. 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

         0

      type

      Investigator Decision Due to Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Pheresis Lot Failure, Not Proceeding to Chemotherapy or car-t Infusion

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         1

      type

      STARTED

   2. achievements

      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

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         12

      4. group Id

         FG003

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

29 participants were screened (Substudy A:1; Substudy B: 10; Substudy C: 16; Substudy D: 2). Substudy A was withdrawn, prior to enrollment of any participants. Therefore, the results below are reported only for Substudies B, C, and D.

recruitment Details

Participants were enrolled at study sites in Netherlands, Italy, Germany, Switzerland, Spain, and the United States.

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Preserved source evidence · Not medical advice