RecruitingPhase 1

Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas

United States24 participantsStarted 2026-12-24

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial focused on finding the maximum tolerated dose and tracking adverse events, what does that mean for what we actually know so far about whether these CAR T cells help shrink tumors — and is the main goal here safety testing rather than proving it works?
2This trial uses CAR T cells engineered to target two proteins, EGFR and IL13Rα2, and delivers them directly into the brain — what kinds of side effects are doctors most concerned about with that kind of locoregional approach, and how are they monitored and managed?
3My diagnosis is recurrent or progressive high-grade glioma, which means I've already been through prior treatment — given where I am in my treatment history, would you consider this trial a reasonable next step, or are there standard salvage options I should try first?
4What does 'locoregional administration' actually involve in practice — would I need surgery or an implanted device to receive the CAR T cells directly into my brain, and how does that affect my day-to-day life during the trial?
5If I enroll and the trial finds this dose isn't safe for me, or if my disease progresses while I'm on the study, what happens next — would I still have other treatment options available to me?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events

Timeframe: Up to 15 years

Maximum tolerated dose (MTD)

Timeframe: Up to 5 years

Trial details

NCT IDNCT07544992

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-11-04

View on ClinicalTrials.gov More Recurrent Astrocytoma, IDH-Mutant, Grade 4 trials