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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 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
~2030
Cyclophosphamide
2010
Completed Phase 4
~2310
Axicabtagene Ciloleucel
2020
Completed Phase 2
~510
Computed Tomography
2017
Completed Phase 2
~2790
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

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.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,660 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,220 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,185 Total Patients Enrolled
Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,805 Total Patients Enrolled
Brian T HessPrincipal InvestigatorSWOG Cancer Research Network

Media Library

Step I (lymphodepleting chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05633615 — Phase 2
Follicular Lymphoma Research Study Groups: Step II Arm IV (observation), Step I (lymphodepleting chemotherapy), Step II Arm I (mosunetuzumab), Step II Arm II (polatuzumab vedotin), Step II Arm III (polatuzumab vedotin, mosunetuzumab)
Follicular Lymphoma Clinical Trial 2023: Step I (lymphodepleting chemotherapy) Highlights & Side Effects. Trial Name: NCT05633615 — Phase 2
Step I (lymphodepleting chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05633615 — Phase 2
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