Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma

This open-label, multicenter, three cohorts, phase II study is designed to assess a combination of Zanubrutinib/Venetoclax/Glofitamab or Venetoclax/Glofitamab in high-risk subjects with either first line or R/R Mantle Cell Lymphoma (MCL). Three independent cohorts will be run: * Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment (POD 24). * Cohort B will be open for subjects with R/R MCL and refractory or progressive to a BTK inhibitor given previously (\>24 months if first line). * Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features.

NCT Number	NCT06558604
Lead Sponsor	The Lymphoma Academic Research Organisation Collaborators: BeiGene, Hoffmann-La Roche
Conditions	Lymphoma, Mantle-Cell
Enrollment	100 participants
Start Date	2025-02-21
Primary Completion	2028-05 (estimated)
Study Completion	2032-03 (estimated)
Updated on ClinicalTrials.gov	2026-07-10