Clinical Trial

Study of BGB-11417 Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

Active, Not Recruiting Phase 1/2
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Summary
The study consists of two parts. Part 1 determines the safety and tolerability of BGB-11417 (sonrotoclax) monotherapy, the maximum tolerated dose, and the recommended Phase 2 dose of BGB-11417 monotherapy for relapsed or refractory mantle cell lymphoma. Part 2 evaluates efficacy of BGB-11417 monotherapy at the recommended Phase 2 dose with recommended ramp-up schedule from Part 1.
Protocol Amendment History 24 amendments
This ClinicalTrials.gov record has been amended 24 times since 2022-07-21; most recent amendment 2025-09-05.
Status change: Recruiting → Active, Not Recruiting 2024-10-24
Status change: Not Yet Recruiting → Recruiting 2022-10-17
Trial Details
NCT Number NCT05471843
Lead Sponsor BeiGene
Conditions Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma (MCL), Relapsed Mantle Cell Lymphoma
Enrollment 125 participants
Start Date 2022-09-05
Primary Completion 2025-07-18 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-09-09