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OncoMatch/Clinical Trials/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)

Is NCT06742996 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Sonrotoclax and Zanubrutinib for mantle cell lymphoma.

Phase 3RecruitingBeOne MedicinesNCT06742996Data as of Jun 2026Location: International · 17 countries

Treatment: Sonrotoclax · ZanubrutinibThe 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.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Zanubrutinib

Other

Sonrotoclax

Cancer type

Non-Hodgkin Lymphoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 5 prior lines
Min 1 prior line

Must have received: anti-CD20 monoclonal antibody-based immunotherapy or chemoimmunotherapy

Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy

Cannot have received: BCL2 inhibitor

Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)

Cannot have received: BTK degrader

Prior therapy with BTK degraders

Cannot have received: Bruton tyrosine kinase inhibitor

Exception: unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi

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.

Cannot have received: autologous stem cell transplantation

Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug

Cannot have received: chimeric antigen receptor T-cell therapy

Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug

Cannot have received: allogeneic stem cell transplant

Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug

Lab requirements

Blood counts

Kidney function

Liver function

Adequate organ function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Alabama At Birmingham Hospital · Birmingham, Alabama
  • Mayo Clinic Phoenix · Phoenix, Arizona
  • Yale University, Yale Cancer Center · New Haven, Connecticut
  • Memorial Cancer Institute, Memorial Healthcare System · Pembroke Pines, Florida
  • Cleveland Clinic Florida · Weston, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06742996 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior BCL2 inhibitor, BTK degrader, Bruton tyrosine kinase inhibitor disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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