Could a lower dose of this antibody tame Slow-Growing lymphoma?
NCT ID NCT06442475
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This phase II trial is testing whether a low dose of the drug mosunetuzumab can safely and effectively treat people with slow-growing B-cell lymphomas, like follicular and marginal zone lymphoma. The study will enroll 20 adults who have not had prior lymphoma therapy and have low-tumor burden disease. Researchers will monitor tumor shrinkage and side effects to see if this approach offers a less intense treatment option.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mosunetuzumab (a monoclonal antibody)
- What this could lead to
- If it works, this could offer a gentler treatment option for slow-growing B-cell lymphoma, potentially controlling the disease with fewer side effects.
- What could go wrong
- This is a small, early-phase trial with only 20 participants. The drug may not work for everyone, and side effects like cytokine release syndrome are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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