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Taking people in ItalyPhase 3

Tests sonrotoclax with zanubrutinib for returning mantle cell lymphoma

Compares sonrotoclax plus zanubrutinib with placebo plus zanubrutinib in adults with mantle cell lymphoma.

Key facts

Who runs it
BeOne Medicines
Where
Bologna, Lecce, Meldola, Trieste, and Verona, ItalySee the 5 sitesAlso in 16 other countries, 143 sites
Trial code
Registry title
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)
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
5 Mar 2025
Expected to end
30 Mar 2032
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Sonrotoclax
  • Zanubrutinib
  • Placebo
Record updated
29 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with mantle cell lymphoma that came back or did not respond after earlier treatment. It compares sonrotoclax plus zanubrutinib with placebo plus zanubrutinib.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Mantle cell lymphoma that came back or did not respond after the last treatment. At least 1 lesion that can be measured (a node larger than 1.5 cm (0.6 in) or another lesion larger than 1 cm (0.4 in)). ECOG performance status of 0 to 2.
Earlier treatment
Must have had 1 to 5 earlier lines of treatment, including an anti-CD20 antibody-based treatment. Cannot have had earlier BCL2 inhibitor or BTK degrader therapy. Earlier BTK inhibitor therapy is not allowed, unless the person could not tolerate a BTK inhibitor other than zanubrutinib.

Main reasons for not taking part

  • Earlier BCL2 inhibitor or BTK degrader therapy
  • Earlier BTK inhibitor therapy, except intolerance to one other than zanubrutinib
  • Autologous stem cell transplant or CAR T-cell therapy within 3 months before the first dose
  • Allogeneic stem cell transplant within 6 months before the first dose
  • Known lymphoma in the central nervous system

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • History of stroke or intracranial hemorrhage within 6 months before first dose of study drug; Note: Other protocol defined Inclusion/Exclusion criteria may apply
  • Clinically significant cardiovascular disease
  • Known central nervous system involvement by lymphoma

Where in Italy

Also in 16 other countries, 143 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
  • Ospedale Vito Fazzi LecceLecce, ItalyTaking people
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
  • Azienda Sanitaria Universitaria Giuliano IsontinaTrieste, ItalyTaking people
  • Centro Ricerche Cliniche di Verona s.r.l.Verona, ItalyTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm A: sonrotoclax plus zanubrutinibTreatment being tested

    Sonrotoclax and zanubrutinib will be administered in combination.

    Treatment: Sonrotoclax and Zanubrutinib

  • Arm B: placebo plus zanubrutinibPlacebo, for comparison

    Placebo and zanubrutinib will be administered in combination.

    Treatment: Zanubrutinib and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
Plain-language title
Tests sonrotoclax with zanubrutinib for returning mantle cell lymphomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 October 2026