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Monoclonal Antibodies

Mosunetuzumab + Polatuzumab Vedotin for Follicular Lymphoma

Phase 2
Recruiting
Led By Matthew Mei
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

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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate
Incidence of grade 3 or higher adverse events (AEs)
Secondary outcome measures
Duration of response (DOR)
Duration of response among CR (DORC)
Incidence of AEs
+7 more

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
Mosunetuzumab
2019
Completed Phase 2
~140
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Computed Tomography
2017
Completed Phase 2
~2740
Positron Emission Tomography
2011
Completed Phase 2
~2200

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,496 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,841 Previous Clinical Trials
41,002,848 Total Patients Enrolled
Matthew MeiPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
81 Total Patients Enrolled
~27 spots leftby Mar 2028
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