🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06742996
Recruiting Phase 3

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 · tracked via the Priya Life Science China tracker
Sponsor
BeOne Medicines
Phase
Phase 3
Started
2025-03-05
Last updated
2026-09-14

Condition(s) studied

Mantle Cell LymphomaB Cell Lymphoma

Investigational drug(s) / intervention(s)

Sonrotoclax →Zanubrutinib →Placebo

Sonrotoclax: Administered orally

Zanubrutinib: Administered orally

Placebo: Administered orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (155)

FacilityCityRegionStatus
University of Alabama At Birmingham Hospital Birmingham Alabama Recruiting
University of Arizona Cancer Center Tucson Arizona Recruiting
Ucsf Fresno Fresno California Recruiting
Kaiser Permanente Southern California Irvine California Recruiting
Yale University Yale Cancer Center New Haven Connecticut Recruiting
Memorial Cancer Institute, Memorial Healthcare System Pembroke Pines Florida Recruiting
Cleveland Clinic Florida Weston Florida Recruiting
Rush University Medical Center Chicago Illinois Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana Recruiting
Mission Cancer and Blood Waukee Iowa Recruiting
Our Lady of the Lake Hospital Baton Rouge Louisiana Recruiting
The University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland Recruiting
Dana Farber Cancer Institute Longwood Medical Center Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
The Cancer and Hematology Centers Grand Rapids Michigan Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Hattiesburg Hematology and Oncology Clinic Hattiesburg Mississippi Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Nebraska Cancer Specialists St Francis Grand Island Grand Island Nebraska Recruiting
Nebraska Cancer Specialists Omaha Nebraska Recruiting
The Valley Hospital, Inc Paramus New Jersey Recruiting
Memorial Sloan Kettering Cancer Center Mskcc New York New York Recruiting
Atrium Health Levine Cancer Institute (Lci) Charlotte North Carolina Recruiting
Duke University Durham North Carolina Recruiting
Atrium Health Wake Forest Baptist Winston-Salem North Carolina Recruiting
University Hospitals Cleveland Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
Ohio Health Research Institute Columbus Ohio Recruiting
Penn State Milton S Hershey Medical Center Hershey Pennsylvania Recruiting
McGlinn Cancer Institute West Reading Pennsylvania Recruiting
Tennessee Oncology Nashville St Thomas Midtown Clinic Nashville Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Md Anderson Cancer Center Houston Texas Recruiting
Texas Oncology Austin Midtown Round Rock Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
Virgina Cancer Specialists Gainesville Virginia Recruiting
Vcu Massey Cancer Center Richmond Virginia Recruiting
Northwest Cancer Specialist, Pc(Us Oncology Research) Vancouver Washington Recruiting

+ 115 more sites — see the full list on the official registry below.

On this site

📄 Brukinsa (zanubrutinib) drug profile →

More BeOne Medicines trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06742996 on ClinicalTrials.gov ↗ ← All trials in China