Clinical Trial

A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia

Active, Not Recruiting Phase 2
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Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.
Protocol Amendment History 31 amendments
This ClinicalTrials.gov record has been amended 31 times since 2023-07-18; most recent amendment 2025-12-30.
Status change: Recruiting → Active, Not Recruiting 2025-11-20
Status change: Not Yet Recruiting → Recruiting 2023-09-18
Trial Details
NCT Number NCT05952037
Lead Sponsor BeOne Medicines
Conditions Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Enrollment 114 participants
Start Date 2023-10-23
Primary Completion 2026-09-22 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-01-02