RecruitingPhase 2NCT05389293

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

152 participants

Start Date

May 27, 2022

Study Type

INTERVENTIONAL

Conditions

Lymphoma Follicular Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether mosunetuzumab — a bispecific antibody that connects your immune cells directly to cancer cells to destroy them — either alone or combined with zanubrutinib (a targeted oral drug for blood cancers), can effectively treat follicular lymphoma that has returned or stopped responding to prior treatments. **You may be eligible if...** - You are 18 or older - You have follicular lymphoma (grade 1–3A) that has relapsed or become resistant to prior therapy - Your lymphoma meets established criteria requiring treatment - You are in reasonably good overall health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have grade 3B or transformed follicular lymphoma (more aggressive forms) - Your lymphoma does not currently require systemic treatment - You have active, significant infections or other serious medical conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMosunetuzumab

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.

DRUGZanubrutinib

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.