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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 (CELESTIAL-RRMCL)

NCT06742996

RecruitingPhase 3

Sponsor: BeOne Medicines

Conditions: Mantle Cell Lymphoma, B Cell Lymphoma

Interventions: Sonrotoclax, Zanubrutinib, Placebo

Countries: United States, Argentina, Australia, Austria, Brazil, China, France, Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (155)

Birmingham, Alabama, United States
Tucson, Arizona, United States
Fresno, California, United States
Irvine, California, United States
New Haven, Connecticut, United States
Pembroke Pines, Florida, United States
Weston, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Waukee, Iowa, United States
Baton Rouge, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Hattiesburg, Mississippi, United States
St Louis, Missouri, United States
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
Paramus, New Jersey, United States
New York, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
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