NCT05389293

A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma

An Open-Label, Multicenter, Single-Arm, Sequential Phase-2 Study of Mosunetuzumab Alone or With Zanubrutinib for the Treatment of Patients With Newly Diagnosed Follicular Lymphoma in Need of Systemic Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if mosunetuzumab is an effective treatment in people with follicular lymphoma that was recently diagnosed and have not yet received any treatments for their disease.

Detailed description

After completing enrollment of the initial 53 subjects, the researchers plan to expand the study by an additional 23 subjects.

Conditions

• Follicular Lymphoma
• Lymphoma

Interventions

Type	Name	Description
DRUG	Mosunetuzumab	During Cycle 1, Mosunetuzumab will be administered SC in a step-up dosing schedule at the dose of 5 mg on Day 1, 45 mg on Day 8, and 45 mg on Day 15). Beginning with Cycle 2, Mosunetuzumab will be administered SC at the dose of 45 mg on Day 1. Each Cycle lasts 3 weeks. After the first 8 cycles (approximately 6 months) of therapy, subjects who achieved CR will discontinue therapy, those who attained a PR will receive up to 17 doses (approximately 12 months). Subjects who achieve stable disease (SD) or who experience progressive disease (PD) will be taken off study and subsequent management will be left at the discretion of the investigator.
DRUG	Zanubrutinib	In Cohort 2, Zanubrutinib is concurrently administered continuously starting on Cycle 1, Day -7 and is given for 12 months in both patients with CR and those with PR. Cohort 2 patients with evidence of circulating lymphoma cells at baseline will initiate Zanubrutinib dosing on Cycle 2 Day 1 and continue dosing for 12 months.

Timeline

• Start date: 2022-05-27
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-05-25
• Last updated: 2025-12-31

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study