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Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies

NCT05537766 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-03-10

Study results available
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Summary

Master protocol: The goal of this master clinical study is to test how well the study drug, brexucabtagene autoleucel, works in participants with rare B-cell malignancies: relapsed/refractory Waldenstrom macroglobulinemia (r/r WM) (Substudy A), r/r Richter transformation (RT) (Substudy B), r/r Burkitt lymphoma (BL) (Substudy C) and r/r hairy cell leukemia (HCL) (Substudy D).

Conditions

  • Relapsed/Refractory Waldenstrom Macroglobulinemia
  • Relapsed/Refractory Richter Transformation
  • Relapsed/Refractory Burkitt Lymphoma
  • Relapsed/Refractory Hairy Cell Leukemia

Interventions

BIOLOGICAL

Brexucabtagene Autoleucel

Administered intravenously

DRUG

Cyclophosphamide

Administered intravenously

DRUG

Fludarabine

Administered intravenously

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-01-27
Completion
2025-01-27
FDA Drug
Yes

Countries

  • United States
  • Austria
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05537766 on ClinicalTrials.gov