Low-Dose Mosunetuzumab for Indolent B-Cell Lymphoma
This study is testing a treatment called mosunetuzumab for people with slow-growing (indolent) B-cell lymphoma that has not been treated before. Mosunetuzumab is a type of antibody that might help stop cancer cells from growing and spreading. Researchers want to see how safe and effective a low dose of mosunetuzumab is. You could be eligible if you are 18 or older and have certain types of indolent B-cell lymphoma, such as follicular lymphoma or marginal zone lymphoma, that has not been treated before. The main goal is to see how many people respond to the treatment within about 13 weeks. This study plans to enroll 20 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
- What's involved
- You would receive mosunetuzumab intravenously (through a vein) once a week for four weeks. You would also have blood draws, PET/CT scans, and possibly other scans or sample collections.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you would be followed up at week 13, at 6 months, and then for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06442475
Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentUniversity of WashingtonInvestigator-initiated
~20 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyMagnetic Resonance ImagingMosunetuzumabPositron Emission TomographyQuestionnaire Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response (OR)
Measured over Up to week 13
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Ajay Gopal · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
18 years or older at time of signing informed consent
Capable of understanding and providing written informed consent
Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:
Follicular lymphoma (grade 1-2 or 3A)
Marginal zone lymphoma
Ann Arbor stage II-IV disease
No prior therapy for lymphoma
Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
Nodal or extranodal tumor mass \< 7 cm
Involvement of less than 3 nodal sites with a diameter \> 3 cm
No systemic or B symptoms
No splenomegaly \> 16 cm by imaging
No local risk of vital organ compression
No pleural or peritoneal serous effusions
No leukemic phase (\> 5,0000/ uL circulating lymphocytes)
No significant cytopenias defined as platelets \< 100,000/uL, hemoglobin \< 10 g/dL, or absolute neutrophil count (ANC) \< 1500/ uL
Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm in longest dimension. Measurable disease also includes spleen size more than 13 cm in vertical length
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equation
Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN
Aspartate aminotransferase (AST) ≤ 3 x the ULN
Alanine aminotransferase (ALT) ≤ 3 x the ULN
Gamma glutamyl transferase (GGT) ≤ 3 x the ULN
Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab
Exclusion
History of severe allergic reaction to monoclonal antibody therapy
History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. Malignancies treated curatively or at low-risk of progressing at the judgment of the principal investigator (PI) may be included
Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HbBsAg\] serology):
Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standards
Autoimmune disease requiring active therapy
History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular disease (e.g., New York Heart Association class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
Prior solid organ transplantation
Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab
What this trial measures
- Overall response (OR)Up to week 13
OR will be defined as complete response and partial response at the end of therapy based on the latest version of Lugano criteria. Response rates will be calculated using simple binomial proportions and the corresponding 95% confidence interval will be derived.