NCT05537766

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

A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study will use a basket study design with separate, indication-specific substudies, to investigate r/r RT and r/r BL. After completing the treatment period, all participants will be followed in the post-treatment follow-up period. Thereafter, participants will transition to a separate long-term follow-up study (KT-US-982-5968) to continue follow-up out to 15 years. All substudies have been early terminated by the sponsor. Below is summary of enrollment in each Substudy: * Substudy-A This substudy was withdrawn. Therefore no participants were enrolled. * Substudy-B enrollment closed, actual enrollment is 6. * Substudy-C enrollment closed, actual enrollment is 12. * Substudy-D enrollment closed, actual enrollment is 1.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Brexucabtagene Autoleucel	Administered intravenously
DRUG	Cyclophosphamide	Administered intravenously
DRUG	Fludarabine	Administered intravenously

Timeline

• Start date: 2022-11-01
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2022-09-13
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

26 sites across 8 countries: United States, Austria, France, Germany, Italy, Netherlands, Spain, Switzerland

Regulatory

• FDA-regulated drug study