NCT05389293 · Memorial Sloan Kettering Cancer Center
A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
What this study is about
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.
View original scientific description
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.
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.
Primary outcome measures
Rate of Complete Respons/CR
Time frame: Up to 1 year
The primary objective of the study is to determine the rate of Complete Response/CR to single-agent SC mosunetuzumab according to the 2014 Lugano response criteria in participants with newly diagnosed Follicular Lymphoma in need of systemic therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed Informed Consent Form(s)
- Ability to comply with all the study-related procedures, in the investigator's judgement
- Age 18 years or older
- ECOG performance Status of 0, 1, or 2 \[Appendix 2\]
- Untreated histologically documented FL of grade 1, 2, or 3A
- Stage II bulky (noncontiguous), III, or IV bulky or high burden disease \[Appendix 3\]
- Need of systemic therapy as evidenced by at least one of the following criteria \[also see Appendix 4\]:
- Bulky disease defined as:
- Nodal or extranodal mass \> 7cm in maximum diameter
- ≥ 3 nodal or extranodal sites each with a diameter ≥ 3 cm
- Presence of any of the following constitutional symptoms:
- Fever (\>38C) of unclear etiology
- Night sweats
- Weight loss \>10% within the prior 6 months
- Symptomatic splenomegaly
- Mass-related symptoms
- End-organ damage (e.g., elevated creatinine or elevated liver enzymes) that is clearly related to lymphomatous infiltration in the opin
Where
- Washington D.C., District of Columbia
- Basking Ridge, New Jersey
- Hackensack, New Jersey
- Middletown, New Jersey
- Montvale, New Jersey
- Commack, New York
- Harrison, New York
- New York, New York
- Rockville Centre, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 19, 2026 · Source of record for eligibility and locations