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

NCT05389293 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Lorenzo Falchi, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05389293 on ClinicalTrials.gov