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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 (May 2026). This Phase 3 trial studies multiple treatments including Sonrotoclax and Zanubrutinib for mantle cell lymphoma.

Phase 3RecruitingBeOne MedicinesNCT06742996Data as of May 2026

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

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 →

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