Actively Recruiting
Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
Led by City of Hope Medical Center · Updated on 2026-05-06
24
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR/IL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.
CONDITIONS
Official Title
Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant or legally authorized representative provides documented informed consent.
- Agreement to allow use of archival tumor tissue or approval for exception by Study PI.
- Age 18 years or older.
- Karnofsky Performance Status (KPS) of 70% or higher, Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
- Life expectancy of at least 4 weeks.
- Prior confirmed diagnosis of glioblastoma (IDH-wildtype), grade 4 IDH-mutant astrocytoma, or progressed grade 2/3 astrocytoma consistent with grade 4 IDH-mutant astrocytoma.
- Radiographic evidence of recurrent or progressive measurable disease after standard therapy, at least 12 weeks after completion of initial radiation.
- IL13Ralpha2 expression over 20% by immunohistochemistry and EGFR gene alteration confirmed by molecular testing.
- No known contraindications to leukapheresis, steroids, imaging, or tocilizumab.
- White blood cell count above 2000/dl or absolute neutrophil count at least 1000/mm3.
- Platelet count at least 75,000/mm3.
- Hemoglobin above 8 g/dL.
- Total bilirubin not exceeding 1.5 times the upper limit of normal.
- AST and ALT not exceeding 2.5 times the upper limit of normal.
- Serum creatinine 1.6 mg/dL or lower.
- Oxygen saturation at least 95% on room air.
- Negative tests for HIV antigen/antibody, hepatitis C, and active hepatitis B.
- Women of childbearing potential must have a negative pregnancy test.
- Agreement to use effective birth control or abstain from heterosexual activity during the study and for 3 months after last CAR T cell dose.
You will not qualify if you...
- Currently receiving active bevacizumab therapy.
- Not recovered from toxic effects of previous treatments.
- Received any live vaccine within 30 days before enrollment.
- Uncontrolled seizures or progressive encephalopathy.
- History of allergic reactions to similar compounds as study treatment.
- Significant uncontrolled health conditions.
- Active autoimmune disease requiring systemic immunosuppressive therapy.
- Active infection needing intravenous antibiotics (minor scalp infections allowed).
- Known HIV or hepatitis B or C infection.
- Presence of other active cancers.
- Pregnant or breastfeeding women.
- Any other condition judged by the investigator to make participation unsafe.
- Inability to comply with study procedures or logistics.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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