RecruitingPhase 1NCT04003649

IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM

A Phase 1 Study to Evaluate IL13Rα2-Targeted Chimeric Antigen Receptor (CAR) T Cells Combined With Checkpoint Inhibition for Patients With Resectable Recurrent Glioblastoma


Sponsor

City of Hope Medical Center

Enrollment

60 participants

Start Date

Dec 2, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies the side effects and how well IL13Ralpha2-CAR T cells work when given alone or together with nivolumab and ipilimumab in treating patients with glioblastoma that has come back (recurrent) or does not respond to treatment (refractory). Biological therapies, such as IL13Ralpha2-CAR T cells, use substances made from living organisms that may attack specific glioma cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving IL13Ralpha2-CAR T cells and nivolumab together may work better in treating patients with glioblastoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a cutting-edge immune cell therapy — called IL13Ra2-CAR T cells — for people with glioblastoma (GBM), an aggressive and difficult-to-treat brain tumor. The engineered immune cells are designed to find and attack brain tumor cells. Some patients will also receive immunotherapy drugs (nivolumab and ipilimumab) to see if combining these approaches improves outcomes. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of grade IV glioblastoma (GBM), or a lower-grade glioma that has progressed to GBM - You are in good enough physical condition to receive treatment (KPS ≥ 60%) - You have a life expectancy of at least 4 weeks **You may NOT be eligible if...** - You have uncontrolled infection or serious organ dysfunction - You have certain autoimmune conditions or are on immunosuppressive therapy - You are pregnant or breastfeeding - You have had severe reactions to immunotherapy in the past Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells

Given ITV/ITC

BIOLOGICALIpilimumab

Given IV

BIOLOGICALNivolumab

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04003649


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