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Monoclonal Antibodies

Mosunetuzumab + Polatuzumab for Non-Hodgkin Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

ECOG PS of 0, 1, or 2

Histologically confirmed FL, DLBCL, or MCL

Must not have

Prior allogeneic SCT

Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the safety and effectiveness of two drugs, mosunetuzumab and polatuzumab vedotin, given together intravenously or subcutaneously, in people with various types of non-Hodgkin lymphoma who have relapsed or are refractory to at least two prior lines of systemic therapy.

Who is the study for?

This trial is for adults with certain types of B-cell non-Hodgkin lymphoma who have tried at least one prior treatment. Specifically, it's for those with relapsed or refractory diffuse large B-cell, follicular, or mantle cell lymphoma. Participants should be in a stable enough condition to perform daily activities (ECOG PS 0-2) and must not have had recent CAR-T therapy, stem cell transplants, or certain other treatments.

What is being tested?

The study tests Mosunetuzumab given via IV or SC injection combined with Polatuzumab Vedotin. It starts by finding the right doses and then expands to treat more patients. The goal is to see how safe and effective this combo is for second-line treatment of relapsed/refractory B-cell non-Hodgkin lymphomas.

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, fatigue, nausea, fever from infusion reactions (like chills), potential liver issues indicated by blood test changes, and nerve damage symptoms like numbness.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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My cancer is either follicular lymphoma, diffuse large B-cell lymphoma, or mantle cell lymphoma.

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I have had treatment with an anti-CD20 therapy for my lymphoma.

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I have had at least two treatments for my MCL, including anti-CD20 therapy, a BTK inhibitor, and either anthracycline or bendamustine.

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I have a tumor that can be measured and is larger than 1.5 cm if it's in a lymph node or larger than 1.0 cm if it's outside of lymph nodes.

Exclusion Criteria

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

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I have had a stem cell transplant from a donor.

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I have a confirmed history of PML.

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I have or had brain lymphoma or disease.

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I have been treated with polatuzumab vedotin before.

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I do not have severe numbness, tingling, or pain in my hands or feet.

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I have or might have had HLH.

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I have had a solid organ transplant.

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I have previously been treated with mosunetuzumab or similar medications.

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I have not had radiotherapy in the last 2 weeks.

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I had a stem-cell transplant using my own cells less than 100 days ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCLExperimental Treatment3 Interventions

Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin.

Group II: Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCLExperimental Treatment3 Interventions

2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin.

Group III: Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCLExperimental Treatment4 Interventions

2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin.

Group IV: Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FLExperimental Treatment3 Interventions

Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.

Group V: Dose FindingExperimental Treatment3 Interventions

Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~2990

Tocilizumab

2012

Completed Phase 4

~1840