Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia

• Status: Recruiting
• Trial end date: 2028-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene

Criteria

Inclusion Criteria:

• Clinical and definitive histologic diagnosis of WM.

• Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).

• Refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.

• Adequate organ function.

Exclusion Criteria:

• Central nervous system (CNS) involvement by WM.

• Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.

• History of other malignancies ≤ 2 years before study entry.

• Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.