A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma

BeiGene

Status and phase: Enrolling; Phase 3

Conditions: B Cell Lymphoma; Mantle Cell Lymphoma

Treatments: Drug: Sonrotoclax; Drug: Placebo; Drug: Zanubrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06742996

CTR20250207 (Registry Identifier)

2024-515593-27-00 (EU Trial (CTIS) Number)

BGB-11417-302

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC)
• 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
• 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Arm A: sonrotoclax plus zanubrutinib

Experimental group

Description:

Sonrotoclax and zanubrutinib will be administered in combination.

Treatment:

Drug: Zanubrutinib

Drug: Sonrotoclax

Arm B: placebo plus zanubrutinib

Placebo Comparator group

Description:

Placebo and zanubrutinib will be administered in combination.

Treatment:

Drug: Placebo

Drug: Zanubrutinib