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RECRUITING
NCT04003649
PHASE1

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2019-12-02

Completion Date

2026-05-26

Last Updated

2025-07-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells

Given ITV/ITC

BIOLOGICAL

Ipilimumab

Given IV

BIOLOGICAL

Nivolumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (1)

City of Hope Medical Center

Duarte, California, United States