drugset / Trial / NCT07555470

Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma

NCT07555470

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this prospective, multicenter, Phase 2 study is to evaluate the efficacy and safety of Mosunetuzumab in combination with the EZH2 inhibitor Zeprumetostat (SHR2554) in patients with follicular lymphoma (FL). The study plans to enroll approximately 80 patients, who will be assigned to three distinct cohorts: previously untreated high-risk FL (Cohort 1), previously untreated low-tumor-burden FL (Cohort 2), and relapsed or refractory FL (Cohort 3). The study consists of a safety run-in phase, which will be initially conducted in Cohort 1 to assess the tolerability of the combination therapy, followed by an expansion phase across all three cohorts to further evaluate the clinical outcomes.

Timeline

Start
2026-04-10
Primary completion
2029-12-31
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Mosunetuzumab Monoclonal antibody 30 mg Intravenous
Subject Zeprumetostat Small molecule 350 mg Oral

Indications