Actively Recruiting
A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-01-21
36
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining two drugs, mosunetuzumab and zanubrutinib, in treating patients with relapsed or refractory marginal zone lymphoma (MZL), a type of lymphoma that has returned or not responded to previous treatment. This Phase 2 trial aims to measure how well this combination works by looking at complete response rates and other important outcomes like overall survival and progression-free survival. The study also explores the role of tumor volume and biomarkers in predicting treatment response and resistance. Participants will receive mosunetuzumab and zanubrutinib, both given intravenously, as part of the treatment regimen. The study focuses on patients who have had at least one prior therapy including a CD20 monoclonal antibody and have stage II, III, or IV disease. The trial does not use any placebo or masking techniques, and all participants receive the investigational combination therapy. The treatment period and additional study details are structured to assess the combination's safety and efficacy over time. During the study, participants will be closely monitored for safety and adverse events for about one year after treatment begins. Researchers will conduct evaluations including imaging tests to measure tumor size, laboratory tests to assess organ function, and clinical assessments following established criteria. The study’s main outcome is tracking safety and adverse events, with ongoing follow-up to assess response duration and survival. Participants may expect regular visits and tests to monitor their health throughout the trial.
CONDITIONS
Brief Title
A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically diagnosed marginal zone lymphoma, including any subtypes or low-grade B-cell lymphoma unclassifiable
- Received at least one prior treatment including a CD20 monoclonal antibody
- Relapsed or refractory disease after most recent treatment
- Stage II, III, or IV disease
- Age 18 years or older
- Performance status of 2 or less on the ECOG scale (up to 3 if due to lymphoma)
- Requires systemic therapy based on tumor size, symptoms, or GELF criteria
- Bi-dimensionally measurable disease with at least one nodal lesion 1.5 cm or larger or one extra-nodal lesion over 1 cm
- Adequate organ and marrow function as specified by laboratory thresholds
You will not qualify if you...
- Active central nervous system lymphoma or leptomeningeal disease
- Treatment with chemotherapy or other anti-lymphoma agents within 4 weeks or five half-lives before study drug
- Other malignancy within 3 years except certain treated localized cancers
- Life-threatening illness or organ dysfunction that may affect safety or study outcomes
- Uncontrolled HIV, active Hepatitis B or C infection, or other significant infections
- History of immunodeficiency or recent systemic immunosuppressant therapy
- Use of strong/moderate CYP3A inhibitors or inducers near study start
- Significant cardiovascular disease or recent major cardiac events
- Abnormal ECG findings such as certain heart blocks
- Active bleeding disorders or history of recent stroke or intracranial hemorrhage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Through study completion; an average of 1 year
Participants receive mosunetuzumab and zanubrutinib as combination drug therapy for relapsed or refractory marginal zone lymphoma.
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
D
Dai Chihara, MD,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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