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Monoclonal Antibodies

Treatment w/Mosunetuzumab + Zanubrutinib for Lymphoma

Phase 2
Waitlist Available
Led By Dai Chihara, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically diagnosed marginal zone lymphoma (any subtypes) Low grade lymphoma unclassifiable is also eligible Have received at least 1 prior treatment including CD20 monoclonal antibody Stage II, III or IV disease Age ≥18 years. Because no dosing or adverse event data are currently available on the use of mosunetuzumab and zanubrutinib combination in patients \<18 years of age, children are excluded from this study.
Performance status ≤2 on the ECOG scale (≤3 if due to lymphoma) Requiring systemic therapy assessed by investigator based on tumor size, symptoms and/or GELF criteria42 A nodal or extranodal (except spleen) mass \> 7 cm in its greater diameter At least 3 nodal or extranodal sites ≥ 3 cm in diameter Presence of at least one B symptom Fever (\>38 ℃), night sweats, weight loss \> 10% in the past 6 months Symptomatic splenomegaly (or size \>13cm) Impending organ compression or involvement (ureteral, orbital, gastrointestinal) Any of the following cytopenias due to bone marrow involvement of lymphoma Hemoglobin ≤ 10 g/dL Platelets ≤ 100 x 109/L Absolute neutrophil count (ANC) \< 1.5x109/L Pleural effusion or ascites LDH \> ULN or β2 microglobulin \> ULN Bi-dimensionally measurable disease, with at least one nodal lesion ≥ 1.5 cm or one extra-nodal lesion \> 1 cm in longest diameter by CT, PET/CT, and/or MRI Subjects with splenic MZL who do not meet the radiographically measurable disease criteria are eligible for participation is spleen is enlarged over 16 cm and MZL is histologically confirmed by bone marrow biopsy or peripheral blood flow cytometry Subjects with EMZL such as skin of conjunctival EMZL who do not meet the radiographically measurable disease criteria are eligible for participation if at least one of the skin lesions is histologically confirmed as MZL and measures ≥1.5 cm in diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

To assess the efficacy and safety of mosunetuzumab combined with zanubrutinib in patients with relapsed or refractory MZL.

Who is the study for?
This trial is for individuals with Marginal Zone Lymphoma (MZL) who have tried other treatments that didn't work or stopped working. Specific eligibility details are not provided, but typically participants need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments.
What is being tested?
The trial is testing the combination of two drugs: Mosunetuzumab and Zanubrutinib, in patients with MZL that has come back after treatment or hasn't responded to previous therapies. It's a Phase 2 trial, which means it focuses on the effectiveness and safety of this drug combo.
What are the potential side effects?
While specific side effects aren't listed here, drugs like Mosunetuzumab and Zanubrutinib can commonly cause reactions such as fatigue, diarrhea, muscle pain, nausea, and increased risk of infections. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Adverse Events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment w/Mosunetuzumab + ZanubrutinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~1940
Mosunetuzumab
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,030 Previous Clinical Trials
1,797,211 Total Patients Enrolled
256 Trials studying Lymphoma
32,543 Patients Enrolled for Lymphoma
Dai Chihara, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
~24 spots leftby Dec 2026
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