OncoMatch/Clinical Trials/NCT04003649
IL13Ra2-CAR T Cells With or Without Nivolumab and Ipilimumab in Treating Patients With GBM
Is NCT04003649 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells and Ipilimumab for recurrent glioblastoma.
Treatment: IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells · Ipilimumab · Nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IL13RA2 overexpression (IHC H-score > 50)
IL13Rα2+ tumor expression by IHC at the initial tumor presentation or recurrent disease (H-score > 50)
Disease stage
Required: Stage WHO GRADE IV (WHO)
Grade: IV (WHO)
WHO classification grade IV GBM, or ... radiographic progression consistent with a grade IV GBM
Prior therapy
Must have received: standard therapy — front-line
radiographic evidence of recurrence/progression of measurable disease after standard therapy, and ≥ 12 weeks after completion of front-line radiation therapy
Cannot have received: anti-CTLA-4 therapy
Prior CTLA-4 ... inhibitor therapy.
Cannot have received: anti-PD-1 therapy
Prior ... PD-1 ... inhibitor therapy.
Cannot have received: anti-PD-L1 therapy
Prior ... PD-L1 inhibitor therapy.
Lab requirements
Blood counts
WBC > 2000/dl (or ANC ≥ 1,000/mm3); Platelets ≥ 75,000/mm3; Fasting Blood glucose within ULN
Kidney function
Serum creatinine ≤1.6 mg/dL
Liver function
Total bilirubin ≤ 1.5 ULN; AST ≤ 2.5x ULN; ALT ≤ 2.5x ULN
Cardiac function
O2 saturation ≥ 95% on room air; EKG and Echocardiogram (ECHO) required for participants with cardiac risk factors
WBC > 2000 /dl (or ANC ≥ 1,000/mm3); Platelets ≥ 75,000/mm3; Fasting Blood glucose within ULN; Total bilirubin ≤ 1.5 ULN; AST ≤ 2.5x ULN; ALT ≤ 2.5x ULN; Serum creatinine ≤1.6 mg/dL; O2 saturation ≥ 95% on room air; EKG and Echocardiogram (ECHO) required for participants with cardiac risk factors
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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