Kite's ZUMA-2 Cohort 3 trial in BTKi-naive mantle cell lymphoma completes, results posted

Kite, a Gilead company, posted updates this week on its ongoing brexucabtagene autoleucel (KTE-X19, Tecartus) program in mantle cell lymphoma.

• **Study**: "A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (ZUMA-2)," Cohort 3, sponsored by Kite. The trial is listed as completed, with primary and study completion dated 2025-06-17 and results first posted 2026-08-18. This cohort was added to fulfill an FDA postmarketing requirement and enrolled participants with relapsed/refractory MCL treated with up to five prior regimens who had not received a Bruton's tyrosine kinase inhibitor.¹ Enrollment reached 95 participants¹, and the primary outcome measured was percentage of participants with objective response per the Lugano Classification according to Independent Radiology Review Committee assessment¹. Treatment included a fludarabine and cyclophosphamide conditioning regimen followed by a single infusion of brexucabtagene autoleucel at a target dose of 2×10^6 anti-CD19 CAR T cells per kg¹. Participants who received the CAR T infusion will continue in a separate long-term follow-up study, KT-US-982-5968 (NCT05041309), for the remainder of a 15-year follow-up period¹.