drugset / Trial / NCT04003649

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

NCT04003649 ↗

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-12-02
Primary completion
2024-12-18
Completion
2026-09-26

Drugs

EvaluationDrugModalityDoseRoute
Subject IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells Cell therapy — Other
Subject Ipilimumab Monoclonal antibody — Intravenous
Subject Nivolumab Monoclonal antibody — Intravenous

Indications