Recruiting

Phase 3

Sonrotoclax & ZanubrutinibA 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)

Sponsor:

BeOne Medicines

Code:

NCT06742996

Conditions

Mantle Cell Lymphoma

B Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonrotoclax

Zanubrutinib

Placebo

Study Details

Brief summary:

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.

Conditions

Mantle Cell Lymphoma

B Cell Lymphoma

Study ID

NCT06742996

Start date

Mar 5, 2025

Status verified date

Sep, 2026

Completion date

Mar 30, 2032

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: sonrotoclax plus zanubrutinib

Sonrotoclax and zanubrutinib will be administered in combination.

placebo comparator: Arm B: placebo plus zanubrutinib

Placebo and zanubrutinib will be administered in combination.

Interventions

Sonrotoclax

Administered orally

Zanubrutinib

Administered orally

Placebo

Administered orally

Primary outcome measure

Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC) [ Time Frame: Approximately 41 months ]

Central Contacts and Locations

Central contacts

Study Director

1.877.828.5568 clinicaltrials@beonemed.com

Locations

University of Alabama At Birmingham Hospital

Recruiting

Birmingham, Alabama, United States, 35294-0004

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85724-0001

Ucsf Fresno

Recruiting

Fresno, California, United States, 93701

Kaiser Permanente Southern California

Recruiting

Irvine, California, United States, 92618-3734

Yale University Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520-8028

Memorial Cancer Institute, Memorial Healthcare System

Recruiting

Pembroke Pines, Florida, United States, 33026-4119

Cleveland Clinic Florida

Recruiting

Weston, Florida, United States, 33331-3609

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60607

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637-1443

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Mission Cancer and Blood

Recruiting

Waukee, Iowa, United States, 50263

Our Lady of the Lake Hospital

Recruiting

Baton Rouge, Louisiana, United States, 70808-4365

The University of Maryland Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Dana Farber Cancer Institute Longwood Medical Center

Recruiting

Boston, Massachusetts, United States, 02215-5418

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109-1382

The Cancer and Hematology Centers

Recruiting

Grand Rapids, Michigan, United States, 49503-2563

Mayo Clinic Rochester

Recruiting

Rochester, Minnesota, United States, 55905-0001

Hattiesburg Hematology and Oncology Clinic

Recruiting

Hattiesburg, Mississippi, United States, 39401-7233

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110-1010

Nebraska Cancer Specialists St Francis Grand Island

Recruiting

Grand Island, Nebraska, United States, 68803

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130-2042

The Valley Hospital, Inc

Recruiting

Paramus, New Jersey, United States, 07652

Memorial Sloan Kettering Cancer Center Mskcc

Recruiting

New York, New York, United States, 10065-6800

Atrium Health Levine Cancer Institute (Lci)

Recruiting

Charlotte, North Carolina, United States, 28204-2990

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

University Hospitals

Recruiting

Cleveland, Ohio, United States, 44106-1716

Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195-0001

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210-1280

Ohio Health Research Institute

Recruiting

Columbus, Ohio, United States, 43214-3907

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

McGlinn Cancer Institute

Recruiting

West Reading, Pennsylvania, United States, 19611-2143

Tennessee Oncology Nashville St Thomas Midtown Clinic

Recruiting

Nashville, Tennessee, United States, 37205

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37205

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-3907

Texas Oncology Austin Midtown

Recruiting

Round Rock, Texas, United States, 78681-4019

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908-0817

Virgina Cancer Specialists

Recruiting

Gainesville, Virginia, United States, 20155-3257

Vcu Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298-5026

Northwest Cancer Specialist, Pc(Us Oncology Research)

Recruiting

Vancouver, Washington, United States, 98684-6930

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792-0001

More Information

Sponsor

BeOne Medicines

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

mantle cell lymphoma
MCL
relapsed/refractory mantle cell lymphoma
sonrotoclax
BGB-11417

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.