Tests engineered immune cells delivered into the brain for recurrent high-grade glioma

Trial details

Who runs it

City of Hope Medical Center

Trial code

NCT07544992

Record updated

23 October 2026

Original description

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.Read full original descriptionShow less

A Phase 1 Trial to Evaluate the Safety of EGFR/IL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)

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.

Main Inclusion Criteria; Documented informed consent of the participant and/or legally authorized representative; Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval; Age 18 years and older; KPS ≥ 70%, ECOG ≤ 2 (Appendix A); Life expectancy ≥ 4 weeks; Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma; Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy; COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):; IL13Rα2+ expression by IHC > 20, and; EGFR gene-altered by NGS or FISH analysis; No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab; WBC > 2000 /dl (or ANC ≥ 1,000/mm3); Platelets ≥ 75,000/mm3; Hemoglobin > 9g/dL; Total bilirubin ≤ 1.5x ULN; AST ≤ 2.5x ULN; ALT ≤ 2.5x ULN; Serum creatinine ≤1.6 mg/dL; O2 saturation ≥ 95% on room air; Seronegative for HIV Ag/Ab combo, HCV, and active HBV; Women of childbearing potential (WOCBP): negative urine or serum pregnancy test; Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells; Main Exclusion Criteria; Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded; Participant has not yet recovered from toxicities of prior therapy; Participant has received any live vaccine within 30 days prior to enrollment; Uncontrolled seizure activity and/or clinically evident progressive encephalopathy; History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent; Clinically significant uncontrolled illness; Active autoimmune disease requiring systemic immunosuppressive therapy; Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion); Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection; Other active malignancy; Females only: Pregnant or breastfeeding; Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures; Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).

ClinicalTrials.gov NCT07544992