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NCT05537766 · OUTCOME

All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment

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

What was measured

CR Rate is defined as the percentage of participants with CR.

Analysis population: Data cannot be reported for this outcome measure because all substudies were terminated before the central committee could be formed hence central assessment was not performed. There are no plans to analyze these data in the future.

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This substudy was withdrawn; therefore, no participants were enrolled.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 Autoleucel0
Substudy C (Relapsed/Refractory Burkitt Lymphoma): Brexucabtagene Autoleucel0
Substudy D (Relapsed/Refractory Hairy Cell Leukemia): Brexucabtagene Autoleucel0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
CR Rate is defined as the percentage of participants with CR.
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
population Description
Data cannot be reported for this outcome measure because all substudies were terminated before the central committee could be formed hence central assessment was not performed. There are no plans to analyze these data in the future.
reporting Status
POSTED
time Frame
Up to 2 years
title
All Substudies (Substudies A, B, C and D): Complete Response (CR) Rate Determined by Central Assessment
type
SECONDARY

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

Preserved source evidence · Not medical advice