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Investigating a new treatment for Waldenström Macroglobulinemia

An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of the BCL2 Inhibitor Sonrotoclax (BGB-11417) as Monotherapy and in Combination With Zanubrutinib (BGB-3111) in Patients With Waldenström Macroglobulinemia

Phase 2 Interventional BeiGene · NCT05952037

This study is testing a new drug called sonrotoclax to see if it can help adults with Waldenström Macroglobulinemia feel better, either on its own or with another medication, especially for those who haven't had success with other treatments.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment105 (estimated)
Ages18 Years and up
SexAll
SponsorBeiGene Industry-sponsored
Drugs / interventionszanubrutinib
Locations72 sites (Duarte, California and 71 other locations)
Trial IDNCT05952037 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of the BCL2 inhibitor sonrotoclax (BGB-11417) in adults with Waldenström Macroglobulinemia, both as a standalone treatment for those who have not responded to previous therapies and in combination with zanubrutinib for previously untreated patients. The study aims to determine the proportion of participants who achieve cancer remission or experience symptom improvement, as well as to monitor any adverse effects from the treatments. Approximately 105 participants will be enrolled, and the study will take place across multiple centers worldwide over a period of about 5 years.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed diagnosis of Waldenström Macroglobulinemia, especially those with relapsed or refractory disease or those who have not yet received treatment.

Not a fit: Patients with central nervous system involvement by Waldenström Macroglobulinemia or those who have transformed to aggressive lymphoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with Waldenström Macroglobulinemia, particularly those who have not responded to existing therapies.

How similar studies have performed: While the approach of targeting BCL2 proteins is promising, this specific combination treatment is novel and has not been extensively tested in previous studies.

Eligibility criteria

Show full inclusion / exclusion 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).
* For Cohorts 1-3, refractory or relapsed disease 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.
* For Cohort 4, patients must not have received prior therapy for WM (except for plasmapheresis).
* 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.

Where this trial is running

Duarte, California and 71 other locations

+22 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Waldenstrom MacroglobulinemiaWaldenstrom's Macroglobulinemia RecurrentWaldenstrom's Macroglobulinemia RefractoryWaldenström's macroglobulinemiaLymphomaBGB-11417BCL-2i
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.