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)

A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: BeOne Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Mantle Cell Lymphoma
• B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Sonrotoclax	Administered orally
DRUG	Zanubrutinib	Administered orally
DRUG	Placebo	Administered orally

Timeline

• Start date: 2025-03-05
• Primary completion: 2028-08-31
• Completion: 2032-03-30
• First posted: 2024-12-19
• Last updated: 2026-03-19

Locations

149 sites across 17 countries: United States, Argentina, Australia, Austria, Brazil, China, France, Germany, Italy, Japan, New Zealand, Poland, Puerto Rico, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study