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

Sponsor: BeiGene

Sponsor score: 40

ClinicalTrials ID:NCT06742996

This clinical trial evaluates the efficacy and safety of sonrotoclax plus zanubrutinib versus placebo plus zanubrutinib in adults with relapsed/refractory mantle cell lymphoma. Eligible participants must have a confirmed MCL diagnosis, prior systemic therapy, measurable disease, ECOG status 0-2, and adequate organ function. Interventions include oral administration of sonrotoclax, zanubrutinib, and placebo.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
University of Alabama At Birmingham Hospital35294-0004BirminghamAlabama
Mayo Clinic Phoenix85054-4502PhoenixArizona
Yale University, Yale Cancer Center06520-8028New HavenConnecticut
Memorial Cancer Institute, Memorial Healthcare System33026-4119Pembroke PinesFlorida
Cleveland Clinic Florida33331-3609WestonFlorida
Rush University Medical Center60612ChicagoIllinois
Fort Wayne Medical Oncology and Hematology46804Fort WayneIndiana
Mission Cancer and Blood50263WaukeeIowa
University of Maryland Greenebaum Comprehensive Cancer Center21201-1544BaltimoreMaryland
Dana Farber Cancer Institute Longwood Medical Center02215-5418BostonMassachusetts

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