The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

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.

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

See plan description

See plan description