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Monoclonal Antibodies

Low Dose Mosunetuzumab for Lymphoma

Phase 2

Recruiting

Led By Ajay Gopal

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior systemic therapy (eligible histologies include Follicular lymphoma (grade 1-2 or 3A), Marginal zone lymphoma, Ann Arbor stage II-IV disease)

Low-tumor burden disease as defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria

Must not have

Autoimmune disease requiring active therapy

History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at initiation of study treatment to disease progression, up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a drug called mosunetuzumab on patients with slow-growing B-cell lymphoma to see if it is safe, what side effects it may have, and how well it

Who is the study for?

This trial is for patients with slow-growing B-cell lymphomas, such as Marginal Zone Lymphoma and Follicular Lymphoma. Participants should meet specific health criteria to be eligible.

What is being tested?

The trial is testing the safety and effectiveness of a monoclonal antibody called Mosunetuzumab in treating indolent B-cell lymphoma. It includes tests like CT scans, MRIs, PET scans, and biospecimen collection.

What are the potential side effects?

Possible side effects of Mosunetuzumab may include reactions at the infusion site, fever, fatigue, weakness, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have a type of slow-growing B-cell lymphoma and haven't had treatment yet.

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My cancer is considered to be at an early or controlled stage.

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I am able to get out of my bed or chair and move around.

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My cancer can be measured by scans and shows up on PET scans.

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I am 18 years old or older.

Exclusion Criteria

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

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I am currently receiving treatment for an autoimmune disease.

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I have a history of HLH or MAS.

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I do not have any active and uncontrolled infections.

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I am HIV positive.

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I haven't taken any monoclonal antibody medicine in the last 4 weeks.

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I have had another type of cancer that might interfere with this study's requirements.

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I am taking high doses of corticosteroids.

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I have had an organ transplant.

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I have received treatment for lymphoma before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at initiation of study treatment to disease progression, up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at initiation of study treatment to disease progression, up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at initiation of study treatment to disease progression, up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response (OR)

Secondary study objectives

Incidence of adverse events (AE's)

Incidence of grade 3 or greater cytokine release syndrome (CRS)

Progression free survival (PFS)

+2 more

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 (mosunetuzumab)Experimental Treatment6 Interventions

Patients receive mosunetuzumab IV over 2-4 hours on days 1, 8, 15 and 22. Patients also undergo blood sample collection and PET/CT on study. Patients may undergo CT and/or MRI as clinically indicated and may undergo collection of oral and/or rectal swabs on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mosunetuzumab

2019

Completed Phase 2

~140

Computed Tomography

2017

Completed Phase 2

~2740