NCT06742996From ClinicalTrials.govRecruiting

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)

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

Mantle Cell Lymphoma
B Cell Lymphoma

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 300
Started: 5 March 2025
Main results due: 31 August 2028
Study sites: 150
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(150)

University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States
Recruiting
University of Arizona Cancer Center
Tucson, Arizona, United States
Recruiting
Ucsf Fresno
Fresno, California, United States
Recruiting
Kaiser Permanente Southern California
Irvine, California, United States
Recruiting
Yale University Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida, United States
Recruiting
Cleveland Clinic Florida
Weston, Florida, United States
Recruiting
Rush University Medical Center
Chicago, Illinois, United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois, United States
Recruiting
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Recruiting
Mission Cancer and Blood
Waukee, Iowa, United States
Recruiting
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States
Recruiting
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Recruiting
Dana Farber Cancer Institute Longwood Medical Center
Boston, Massachusetts, United States
Recruiting
University of Michigan
Ann Arbor, Michigan, United States
Recruiting
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, United States
Recruiting
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Recruiting
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, United States
Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Recruiting
The Valley Hospital, Inc
Paramus, New Jersey, United States
Recruiting
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Recruiting
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Recruiting
Duke University
Durham, North Carolina, United States
Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Recruiting
University Hospitals
Cleveland, Ohio, United States
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Recruiting
Ohio Health Research Institute
Columbus, Ohio, United States
Recruiting
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Recruiting
McGlinn Cancer Institute
West Reading, Pennsylvania, United States
Recruiting
Tennessee Oncology Nashville St Thomas Midtown Clinic
Nashville, Tennessee, United States
Recruiting
Tennessee Oncology
Nashville, Tennessee, United States
Recruiting
Md Anderson Cancer Center
Houston, Texas, United States
Recruiting
Texas Oncology Austin Midtown
Round Rock, Texas, United States
Recruiting
University of Virginia
Charlottesville, Virginia, United States
Recruiting
Virgina Cancer Specialists
Gainesville, Virginia, United States
Recruiting
Vcu Massey Cancer Center
Richmond, Virginia, United States
Recruiting
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States
Recruiting
University of Wisconsin
Madison, Wisconsin, United States
Recruiting
Hospital Aleman
Caba, Argentina
Recruiting
FUNDALEU
Caba, Argentina
Active, not recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Active, not recruiting
Hospital Universitario de Cordoba
Córdoba, Argentina
Active, not recruiting
Genesiscare North Shore
St Leonards, New South Wales, Australia
Recruiting
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Active, not recruiting
Box Hill Hospital
Box Hill, Victoria, Australia
Active, not recruiting
Monash Health
Clayton, Victoria, Australia
Active, not recruiting
Rockingham Hospital
Cooloongup, Western Australia, Australia
Active, not recruiting
Linear Clinical Research
Nedlands, Western Australia, Australia
Recruiting
One Clinical Research
Nedlands, Western Australia, Australia
Recruiting
Perth Blood Institute
West Perth, Western Australia, Australia
Active, not recruiting
Uk St Poelten
Sankt Pölten, Austria
Active, not recruiting
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil
Active, not recruiting
Hospital Felicio Rocho
Belo Horizonte, Brazil
Active, not recruiting
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, Brazil
Active, not recruiting
Hospital Erasto Gaertner
Curitiba, Brazil
Active, not recruiting
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Brazil
Active, not recruiting
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, Brazil
Active, not recruiting

Showing 60 of 150 sites — filter to narrow it down. 102 of the 150 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06742996. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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