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Comparing sonrotoclax plus zanubrutinib to placebo plus zanubrutinib for relapsed mantle cell lymphoma

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

PHASE3 · BeOne Medicines · NCT06742996

This study is testing if adding sonrotoclax to zanubrutinib can help adults with relapsed mantle cell lymphoma feel better compared to just taking zanubrutinib with a placebo.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment300 (estimated)
Ages18 Years and up
SexAll
SponsorBeOne Medicines (industry)
Drugs / interventionszanubrutinib, chimeric antigen receptor, immunotherapy
Locations149 sites (Birmingham, Alabama and 148 other locations)
Trial IDNCT06742996 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of sonrotoclax combined with zanubrutinib compared to a placebo combined with zanubrutinib in adults suffering from relapsed or refractory mantle cell lymphoma (MCL). Participants will have received between one to five prior lines of systemic therapy and will be assessed for measurable disease. The study will monitor treatment outcomes and adverse effects to determine the potential benefits of the new combination therapy.

Who should consider this trial

Good fit: Ideal candidates include adults with a confirmed diagnosis of relapsed or refractory mantle cell lymphoma who have undergone previous systemic therapies.

Not a fit: Patients who have previously received therapy with B-cell lymphoma-2 inhibitors or certain Bruton tyrosine kinase inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory mantle cell lymphoma.

How similar studies have performed: Other studies have shown promise with similar therapeutic approaches, but this specific combination is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
* Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
* Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
* Relapsed or refractory disease after the last line of therapy
* Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Adequate organ function

Exclusion Criteria:

* Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
* Prior therapy with BTK degraders
* Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
* Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
* Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
* Known central nervous system involvement by lymphoma
* Clinically significant cardiovascular disease
* History of stroke or intracranial hemorrhage within 6 months before first dose of study drug

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

Where this trial is running

Birmingham, Alabama and 148 other locations

+99 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 →

Conditions: Mantle Cell Lymphoma, B Cell Lymphoma, mantle cell lymphoma, MCL, relapsed/refractory mantle cell lymphoma, sonrotoclax, BGB-11417

Last reviewed 2026-05-15 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.