NCT06492837

Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients

A Phase II Trial Investigating MOsunetuzumab and ZAnubrutinib (BGB-3111) in Relapsed/refracTory Follicular Lymphoma Patients (MOZART)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multicenter study evaluating the efficacy and safety of mosunetuzumab + zanubrutinib (M+Z) used as salvage strategy in patients with R/R FL who have received at least one line of prior systemic therapy.

Detailed description

Eligible patients receive a pre-phase with oral zanubrutinib followed by an induction phase with mosunetuzumab combined with oral zanubrutinib. Patients responsive to induction phase with M+Z (C1-12) and achieving at least SD will receive maintenance with zanubrutinib for additional 12 months (C13-24). There will be an initial safety run-in (SRI) phase of 10 patients which will be closely monitored for the observed toxicities during the first three cycles of induction (from C1D1 to C3D28). No patients will be further enrolled until SRI analyses is completed. If no unexpected toxicity has been observed, subsequent patients will be monitored only for patient informed consent, grade 3-5 toxicities and SAEs as well as remission status. Safety data will be evaluated by an independent data safety monitoring board (DSMB) that will advise the principal investigators on the continuation of the study. Safety events will be analyzed and compared with the previously described safety profile of mosunetuzumab alone and other bispecific-containing regimens to exclude the risk of potential toxicity for all study participants.

Conditions

• Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab in combination with Zanubrutinib	Combinations of Mosunetuzumab and Zanubrutinib as salvage strategy in patients with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

Timeline

• Start date: 2024-10-23
• Primary completion: 2028-09-15
• Completion: 2033-09-15
• First posted: 2024-07-09
• Last updated: 2026-01-28

Locations

24 sites across 2 countries: Australia, Italy