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NCT05537766 · OUTCOME

All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 2 years

Analysis population: Participants in substudies B, C and D, in the Safety Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.

Groups in this outcome

Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel

This substudy was withdrawn; therefore, no participants were enrolled.

Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel

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.

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

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.

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

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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Substudy A (Relapsed/Refractory Waldenstrom Macroglobulinemia): Brexucabtagene Autoleucel0
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel4
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel10
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel1

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Substudy B (Relapsed/Refractory Richter Transformation): Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel1Not reportedNot reportedNot reportedNot reported
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel0Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        value
        0
      2. group Id
        OG002
        value
        1
      3. group Id
        OG003
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      1
    units
    Participants
groups
  1. description
    This substudy was withdrawn; therefore, no participants were enrolled.
    id
    OG000
    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
    OG001
    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
    OG002
    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
    OG003
    title
    Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants in substudies B, C and D, in the Safety Analysis Set were analyzed. Substudy A was withdrawn, therefore no participants were enrolled in it. Hence, data is not available.
reporting Status
POSTED
time Frame
Up to 2 years
title
All Substudies (Substudies A, B, C and D): Number of Participants With Positive Anti-brexucabtagene Autoleucel Antibodies
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice