Actively Recruiting
A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-31
152
Participants Needed
9
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form(s)
- Ability to comply with study procedures as judged by investigator
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- Untreated histologically confirmed follicular lymphoma (grade 1, 2, or 3A)
- Stage II bulky (noncontiguous), III, or IV bulky or high burden disease
- Need for systemic therapy based on criteria such as bulky disease or symptoms
- Considered a potential candidate for chemoimmunotherapy by treating physician
- At least one measurable lesion by CT or MRI
- Agreement to provide tumor samples including biopsies before and after first dose of mosunetuzumab
- Adequate liver function (AST and ALT ≤3x ULN; bilirubin ≤1.5x ULN except Gilbert syndrome)
- Adequate bone marrow function (platelets ≥75 x 10^9/L; ANC ≥1 x 10^9/L; hemoglobin ≥9 g/dL)
- Creatinine ≤ ULN or creatinine clearance ≥45 mL/min
- For women of childbearing potential: agreement to use effective contraception or abstinence during treatment and for 3 months after last dose
- For men: agreement to use condoms or abstinence during treatment and for 60 days after last dose
You will not qualify if you...
- Inability to comply with study procedures
- Follicular lymphoma grade 3B or transformed follicular lymphoma
- Not meeting criteria for systemic therapy
- Unfit for chemoimmunotherapy due to age or comorbidities
- Follicular lymphoma localized only to certain extranodal sites (e.g., duodenal, cutaneous, testis)
- Pediatric follicular lymphoma
- Prior anti-lymphoma therapy
- Prior solid organ transplantation
- Prior allogeneic stem cell transplantation within 5 years
- Current or prior central nervous system lymphoma or significant CNS disease
- Significant cardiovascular disease or active pulmonary disease
- Active infections or major infection requiring IV antibiotics within 4 weeks
- Active or suspected chronic viral infections (HBV, HCV, HIV)
- Recent use of live vaccines or planned use during the study
- Pregnant or lactating women or intending pregnancy during study and for 3 months after
- Recent radiation therapy or major surgery within 4 weeks
- History of autoimmune diseases unless well controlled or specific exceptions
- History of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy (PML)
- Severe allergic reactions to monoclonal antibody therapy
- History of other malignancies unless treated and in remission
- Recent use of systemic immunosuppressive medications except limited corticosteroids
- History of illicit drug or alcohol abuse within last 12 months
- Any medical condition or lab abnormality precluding safe participation
- Cohort 2 only: use of strong CYP3A inhibitors/inducers, bleeding disorders, inability to swallow capsules, recent consumption of grapefruit or related products
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Georgetown University (Data Collection Only)
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Hackensack Meridian Health (Data collection only)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
5
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
6
Memorial Sloan Kettering Suffolk- Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
7
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, United States, 10604
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Limited protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
L
Lorenzo Falchi, MD
CONTACT
G
Gilles Salles, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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