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Looking for participantsPhase3

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)

Sponsor: BeOne Medicines

NCT ID: NCT06742996

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sonrotoclax (drug), Zanubrutinib (drug), Placebo (drug)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Sonrotoclax — drug: Administered orally · Zanubrutinib — drug: Administered orally · Placebo — drug: Administered orally
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
300
Started
2025-03-05
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for mantle cell lymphoma
  • • Phase3 - 300 participants
  • • 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)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with mantle cell lymphoma

Where?

  • • Birmingham - Birmingham Heartlands Hospital
  • • Bournemouth - The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
  • • Glasgow - Beatson West of Scotland Cancer Centre
  • • Headington - Oxford University Hospitals Nhs Trust Churchill Hospital
  • • +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Mantle Cell LymphomaB Cell Lymphoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

CD20

What the study is looking for

  • ✓Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis
  • ✓Received 1 to 5 previous treatments including an anti-CD20 monoclonal antibody (mAb)-based treatment that helps your immune system fight cancer...
  • ✓Relapsed or refractory disease after the last line of therapy
  • ✓cancer that can be measured on scans defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that...
  • ✓activity scale (ECOG) Performance Status of 0 to 2

Who cannot take part

  • ✗Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
  • ✗Prior therapy with BTK degraders
  • ✗Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first...
  • ✗Prior allogeneic stem cell transplant within 6 months of the first dose of the the study treatment
  • ✗Known central nervous system involvement by lymphoma
See the full 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.

Where Is This Study? (7 UK sites)

Birmingham Heartlands Hospital

Birmingham B9 5SS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

Bournemouth BH7 7DW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Development & Support

clinicalresearch@bournemouth.ac.uk01202 961200

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Oxford University Hospitals Nhs Trust Churchill Hospital

Headington OX3 7LE, United Kingdom

Recruiting
Hospital R&D contact (matched)

Shahista Hussain

ouhtma@ouh.nhs.uk---

University College Hospital

London NW1 2PG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

Clatterbridge Cancer Centre

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

Derriford Hospital

Plymouth PL6 8DH, United Kingdom

Recruiting

How to Get in Touch

Study Director

Sponsor contact

CONTACT

1.877.828.5568 clinicaltrials@beonemed.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09