What side effects are associated with this type of intervention?

Common treatments for Follicular Lymphoma, such as monoclonal antibodies and antibody-drug conjugates like Mosunetuzumab and Polatuzumab Vedotin, often cause infusion-related reactions (fever, chills, rash), hematologic toxicities (neutropenia, anemia, thrombocytopenia), and gastrointestinal symptoms (nausea, vomiting, diarrhea). Other side effects include fatigue, infections due to immunosuppression, and liver enzyme abnormalities. These therapies generally have more manageable side effects compared to traditional chemotherapy but still require careful monitoring.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies and antibody-drug conjugates for the treatment of Follicular Lymphoma. Rituximab, a monoclonal antibody targeting CD20, was one of the first approved and is often used in combination with chemotherapy. Obinutuzumab, another anti-CD20 monoclonal antibody, has also been approved for use in combination with chemotherapy. Polatuzumab Vedotin, an antibody-drug conjugate targeting CD79B linked to the cytotoxic agent vedotin, is approved for use in combination with bendamustine and rituximab for relapsed or refractory diffuse large B-cell lymphoma, which is similar to its investigational use in Follicular Lymphoma. These treatments work by targeting specific proteins on the surface of cancer cells, thereby interfering with their growth and survival.

What other types of research exist?

Promising novel alternatives for Follicular Lymphoma patients in 2024 include bispecific T cell engagers (BiTEs) such as teclistamab and AMG 701, as well as chimeric antigen receptor (CAR) T-cell therapies like idecabtagene vicleucel and ciltacabtagene autoleucel. Additionally, novel agents targeting cereblon (CELMoDs) like iberdomide and CC92480, and other bispecific antibodies such as talquetamab and cevostamab, are also emerging as potential treatment options.

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Post-CAR T-cell Therapy Drug Combo for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Brian T Hess

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two treatments, mosunetuzumab and polatuzumab vedotin, for patients with certain types of lymphoma that have come back or don't respond to other treatments. These treatments aim to stop cancer cells from growing or kill them directly. The goal is to see if these treatments can better control or shrink the cancer compared to not using them.

Who is the study for?

This trial is for adults with certain types of lymphoma (like diffuse large B-cell or follicular grade IIIb) that's come back or isn't responding to treatment. They should be set for CAR T-cell therapy, have a decent performance score, and functioning major organs. People can't join if they've had recent heart issues, used specific drugs as 'bridging' therapy, or if their CAR T-cells aren't FDA-approved.

What is being tested?

The study tests mosunetuzumab and polatuzumab vedotin in patients who've had chemotherapy followed by CAR T-cell therapy. It aims to see if these drugs help control the cancer better post-CAR T-cell treatment compared to not using them.

What are the potential side effects?

Mosunetuzumab and polatuzumab vedotin might cause side effects like allergic reactions, liver problems from hepatitis B or C reactivation, nerve damage symptoms (peripheral neuropathy), low blood cell counts increasing infection risk, fatigue, and nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Progression free survival (PFS)

Secondary study objectives

Association between total metabolic tumor volume (TMTV), standardized uptake value (SUV) max, and sum product (SPD) of diameters

Complete remission (CR) conversion rate

Conversion of CR

+1 more

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

Active Control

Group I: Step II Arm III (polatuzumab vedotin, mosunetuzumab)Experimental Treatment5 Interventions

Patients receive polatuzumab vedotin IV and mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

Group II: Step II Arm II (polatuzumab vedotin)Experimental Treatment4 Interventions

Patients receive polatuzumab vedotin IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

Group III: Step II Arm I (mosunetuzumab)Experimental Treatment4 Interventions

Patients receive mosunetuzumab IV on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study.

Group IV: Step I (lymphodepleting chemotherapy)Experimental Treatment6 Interventions

Patients receive lymphodepleting chemotherapy consisting of fludarabine IV and cyclophosphamide IV on study. Patients then receive tisagenlecleucel IV, axicabtagene ciloleucel IV, or lisocabtagene maraleucel IV on study.

Group V: Step II Arm IV (observation)Active Control4 Interventions

Patients undergo observation on study. Patients also undergo PET-CT and/or CT and undergo collection of blood and tissue samples throughout the study. Patients with subsequent progression within 12 months of CAR T-cell therapy may crossover to Arm III.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Biospecimen Collection

2004

Completed Phase 3

~2020

Cyclophosphamide

2010

Completed Phase 4

~2310

Axicabtagene Ciloleucel

2020

Completed Phase 2

~510

Computed Tomography

2017

Completed Phase 2

~2740

Polatuzumab Vedotin

2019

Completed Phase 2

~820

Fludarabine

2012

Completed Phase 4

~1860

Mosunetuzumab

2019

Completed Phase 2

~140

Tisagenlecleucel

2019

Completed Phase 2

~370

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Follicular Lymphoma include monoclonal antibodies and antibody-drug conjugates. Monoclonal antibodies, such as Mosunetuzumab, target specific antigens on cancer cells, interfering with their growth and spread. Antibody-drug conjugates, like Polatuzumab Vedotin, combine a monoclonal antibody with a cytotoxic drug, delivering the drug directly to the cancer cells to kill them. This targeted approach is crucial for Follicular Lymphoma patients as it aims to maximize the destruction of cancer cells while minimizing damage to healthy cells, potentially leading to more effective and less toxic treatments.