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Monoclonal Antibodies

Mosunetuzumab + Polatuzumab Vedotin for Follicular Lymphoma

Phase 2

Recruiting

Led By Matthew Mei, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Liver and kidney function within specified limits

Age: ≥ 18 years

Must not have

Known active viral infections (HBV, HCV, HIV), chronic active EBV infection, or CNS involvement by lymphoma

Symptomatic cardiac disease, liver disease, autoimmune diseases, or recent major surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at first pr or cr to progression or death up to 36 months after last dose of protocol therapy

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a combination of two drugs, mosunetuzumab and polatuzumab vedotin, to see how well they work in treating patients with a specific type of

Who is the study for?

This trial is for patients with grade 1-3a follicular lymphoma that has either relapsed or hasn't responded to previous treatments. Participants should have a type of cancer that the drugs used in this study can target.

What is being tested?

The effectiveness of mosunetuzumab and polatuzumab vedotin is being tested on patients with specific types of follicular lymphoma. The trial involves various diagnostic tests like CT, PET, MRI scans, and questionnaires to monitor progress.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, fatigue, nausea, nerve damage symptoms (like numbness or tingling), and low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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My liver and kidney are functioning well.

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I am 18 years old or older.

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I have recovered from side effects of previous cancer treatments.

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My tumor is CD20 positive after my latest treatment.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My cancer has returned or didn't respond after at least one treatment.

Exclusion Criteria

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

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I do not have active viral infections like HBV, HCV, HIV, or chronic EBV.

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I have heart, liver, autoimmune conditions, or had major surgery recently.

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I have moderate to severe numbness, pain, or weakness in my hands or feet.

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I have recently had a stem cell transplant, CAR-T therapy, or specific anti-lymphoma treatments.

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I have not received a live vaccine recently.

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I do not have serious lung conditions like pneumonitis.

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I do not have any uncontrolled illnesses or active infections.

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I have recently been treated with chemotherapy, cancer drugs, or radiation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months after last dose of protocol therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months after last dose of protocol therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months after last dose of protocol therapy for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complete response (CR) rate

Incidence of grade 3 or higher adverse events (AEs)

Secondary study objectives

Duration of response (DOR)

Duration of response among CR (DORC)

Incidence of AEs

+7 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, polatuzumab vedotin)Experimental Treatment7 Interventions

Patients receive polatuzumab vedotin IV over 30-90 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive mosunetuzumab SC on days 1, 8 and 15 of cycle 1 and day 1 of remaining cycles. Cycles repeat every 21 days for up to 8-17 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT, PET/CT, or MRI throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160