Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3)

Phase 2 Completed 95 enrolled Kite, A Gilead Company

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical study is to test how well the study drug, brexucabtagene autoleucel (KTE-X19), works in participants with relapsed/refractory (r/r) mantle cell lymphoma (MCL).

Timeline

Start: 2021-04-27
Primary completion: 2025-06-17
Completion: 2025-06-17

Outcome

Met primary endpoint

paper The primary end point was met, with a 91% ORR (95% confidence interval [CI], 82.5-95.9; P< .0001; N = 86) PMID 41160777 ↗

release “the primary endpoint was met with an ORR of 91%” gilead.com ↗

Publications

van Meerten T, Kersten MJ, Iacoboni G, Hess G, Mutsaers P, Garcia-Sancho AM, Goy A, Gine E, Hill BT, Weng WK, Reagan PM, Patel K, Galal A, Herbaux C, Sanderson R, Forcade E, Topp MS, Houot R, Zheng D, Zhang W, Kanska J, Shen RR, Damico Khalid R, Kloos I, Dreyling M, Wang ML. Brexucabtagene autoleucel for BTKi-naive relapsed/refractory mantle cell lymphoma: primary analysis of ZUMA-2 cohort 3. Blood. 2026 Mar 19;147(12):1302-1314. doi: 10.1182/blood.2025029734.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexucabtagene Autoleucel	Cell therapy	2e+06 cells/kg	—
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous