Clinical Trial

Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL

Recruiting Phase 2
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Summary
This is a phase 2, open-label, randomized, multicenter clinical trial in patients with relapsed/refractory mantle cell lymphoma (R/R MCL) who meet the criteria for standard-of-care FDA label for CD19 CAR T-cell therapy with brexucabtagene autoleucel (brexu-cel).
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2024-08-12; most recent amendment 2026-03-30.
Status change: Not Yet Recruiting → Recruiting 2024-09-03
Trial Details
NCT Number NCT06553872
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Bankhead-Coley Florida Biomedical Research Program, Eli Lilly and Company
Conditions Mantle Cell Lymphoma
Enrollment 60 participants
Start Date 2024-08-23
Primary Completion 2029-08 (estimated)
Study Completion 2029-08 (estimated)
Updated on ClinicalTrials.gov 2026-03-31