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

PHASE2RecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

May 27, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Follicular LymphomaLymphoma
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.

Trial Locations (9)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited protocol activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited protocol activities), Rockville Centre

11725

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities), Commack

20007

RECRUITING

Georgetown University (Data Collection Only), Washington D.C.

07920

RECRUITING

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities, Basking Ridge

07601

RECRUITING

Hackensack Meridian Health (Data collection only), Hackensack

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER