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
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.
CONDITIONS
Official 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 (any subtype), including low grade or indolent B-cell lymphoma unclassifiable
- Received at least 1 prior treatment including CD20 monoclonal antibody
- Relapsed or refractory disease to the most recent treatment
- Disease stage II, III, or IV
- Age 18 years or older
- ECOG performance status 0 to 2 (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 one extra-nodal lesion >1 cm by imaging
- Adequate organ and marrow function as defined in the protocol
You will not qualify if you...
- Active central nervous system lymphoma or leptomeningeal disease
- Recent treatment with chemotherapy or other anti-lymphoma agents within 4 weeks or five half-lives prior to study drug
- Prior history of other malignancy unless disease-free for ≥3 years and low risk for recurrence, except certain skin cancers and cervical carcinoma in situ
- Life-threatening illness, significant organ dysfunction, or condition compromising safety or study outcomes
- Uncontrolled HIV, active hepatitis B or C, or other uncontrolled infections including JC virus and SARS-CoV2
- Immunodeficiency or systemic immunosuppressant therapy within 28 days before study drug, except certain steroids
- Use of strong/moderate CYP3A inhibitors or inducers close to first dose of zanubrutinib
- Significant cardiovascular disease including recent myocardial infarction or severe heart failure
- Certain ECG abnormalities
- Active bleeding disorders or recent stroke or intracranial hemorrhage within 6 months prior to study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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