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Sonrotoclax and Zanubrutinib for Relapsed/Refractory Mantle Cell Lymphoma

This study is testing two oral medications, sonrotoclax and zanubrutinib, to see how well they work together compared to zanubrutinib with a placebo (an inactive substance) for adults with mantle cell lymphoma (MCL) that has come back or not responded to previous treatments. It will also look at the safety of these treatments. You may be able to join if you are an adult (18 years or older) with a confirmed diagnosis of MCL and have received 1 to 5 prior treatments. The main goal is to see how long people live without their cancer getting worse, which will be checked over about 41 months. The study aims to enroll 300 participants, but its current status is unclear.

Study design
This is an interventional study comparing two drug combinations in about 300 participants. It is designed to see if sonrotoclax plus zanubrutinib is more effective than zanubrutinib plus a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess how long they live without their cancer progressing, which will be measured for approximately 41 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06742996

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
BeOne Medicines
~300 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:SonrotoclaxZanubrutinibPlacebo

At a glance

Recruiting sites
106 of 155 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Measured over Approximately 41 months

Conditions

Mantle Cell Lymphoma
B Cell Lymphoma

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Mantle Cell Lymphoma

NCT06742996

Where you'd take part

This study runs at 155 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi-ken, Japanno site contact published

    Recruiting

  • Atrium Health Levine Cancer Institute (Lci)

    Charlotte, North Carolinano site contact published

    Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolinano site contact published

    Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, Puerto Ricono site contact published

    Recruiting

  • Beatson West of Scotland Cancer Centre

    Glasgow, United Kingdomno site contact published

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, Chinano site contact published

    Recruiting

  • Birmingham Heartlands Hospital

    Birmingham, United Kingdomno site contact published

    Recruiting

  • Chiba Cancer Center

    Chiba, Chiba, Japanno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Study Director · STUDY_DIRECTOR · BeOne Medicines

Who to contact

Study Director
[email protected]
1.877.828.5568
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)Approximately 41 months

    PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.