drugset / Trial / NCT05537766

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

NCT05537766

Phase 2 Terminated 19 enrolled Kite, A Gilead Company
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2022-11-01
Primary completion
2025-01-27
Completion
2025-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Brexucabtagene Autoleucel Cell therapy 2e+06 cells/kg Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous