NCT06463691

Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients

An Open-label, Multi-center, Single-arm Study to Evaluate the Efficacy and Safety of Sonrotoclax, Zanubrutinib and CD20mab in Untreated MCL Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a an open-label, multi-center, single-arm study to evaluate the efficacy and safety of sonrotoclax, zanubrutinib and CD20mab in untreated MCL patients.

Detailed description

The benefits of efficacy and survival of immunotherapy regimen in TN MCL is limited, and not all patients are fit for receiving chemotherapy. Considering the balance of toxicity and efficacy, a chemo-free regimen will be a trend in 1L MCL patients. The study is to explore the sonrotoclax, zanubrutinib and CD20mab combination regimen for TN MCL.

Conditions

• MCL

Interventions

Type	Name	Description
DRUG	BGB-11417	Sonrotoclax, orally, 320 mg once daily following a weekly ramp-up schedule
DRUG	BGB-3111	Zanubrutinib, orally, 320 mg total daily dose
DRUG	CD20	CD20mab is recommened as Rituximab as per the protocol, other CD20mab is also allowed.

Timeline

• Start date: 2024-08-01
• Primary completion: 2028-12-01
• Completion: 2029-07-01
• First posted: 2024-06-18
• Last updated: 2025-05-11

Locations

1 site across 1 country: China