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Monoclonal Antibodies

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

Performance status ≤2 on the ECOG scale (≤3 if due to lymphoma)

At least 3 nodal or extranodal sites ≥ 3 cm in diameter

Must not have

Known active central nervous system lymphoma or leptomeningeal disease

Treatment with any chemotherapeutic agent, or treatment with any other anti-lymphoma agent within 4 weeks or five half-lives of the drug prior to first investigational agent administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well a drug called mosunetuzumab works when combined with zanubrutinib in patients with a type of lymphoma called marginal zone lymphoma that has

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

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I can perform daily activities with minimal assistance, more if my condition is lymphoma.

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I have at least 3 large tumors that are 3 cm or bigger.

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My blood counts are low due to lymphoma affecting my bone marrow.

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I have a cancerous lesion that is large enough to be measured accurately.

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I have been diagnosed with marginal zone lymphoma.

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I have had treatment before that includes a CD20 monoclonal antibody.

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My condition is at stage II, III, or IV.

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I am 18 years old or older.

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I have experienced fever, night sweats, or significant weight loss recently.

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My spleen is enlarged or causing symptoms.

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I have fluid buildup in my chest or abdomen.

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I have a tumor larger than 7 cm outside of my spleen.

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My cancer is near or affecting my organs like the ureter, eye area, or digestive system.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active brain or spinal cord lymphoma.

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I haven't had chemotherapy or lymphoma treatment in the last 4 weeks.

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I do not have uncontrolled HIV, Hepatitis B or C, or any severe infection.

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I am on long-term medication that strongly affects liver enzymes.

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I have a bleeding disorder or am currently experiencing active bleeding.

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I have or might have a long-term active Epstein-Barr virus infection.

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I have had a stem cell transplant from a donor.

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I cannot take tocilizumab due to health reasons.

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I have an autoimmune disease treated with medication in the last 2 years.

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I cannot swallow pills or have a condition that affects how my body absorbs medication.

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I have had pneumonitis that needed steroids or currently have pneumonitis.

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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Mosunetuzumab

2019

Completed Phase 2

~140

Zanubrutinib

2017

Completed Phase 3

~2160

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,066 Previous Clinical Trials

1,802,209 Total Patients Enrolled

259 Trials studying Lymphoma

32,499 Patients Enrolled for Lymphoma

Dai Chihara, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Lymphoma

30 Patients Enrolled for Lymphoma

~24 spots leftby Dec 2026

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