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Phase 1 CAR T Cell Trial for Recurrent High-Grade Gliomas

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Summary

This Phase 1 clinical trial registered on ClinicalTrials.gov (NCT07544992) will evaluate the safety and optimal dosing of EGFR/IL13Rα2 pool-CAR T cells administered locoregionally (via intracranial catheter) in patients with recurrent or progressive high-grade gliomas, including recurrent astrocytoma (IDH-mutant, grade 4) and recurrent glioblastoma (IDH-wildtype). The trial involves leukapheresis to collect patient T cells, genetic engineering to express chimeric antigen receptors targeting EGFR and IL13Rα2 proteins on tumor cells, and subsequent infusion of the modified cells.

“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.”

NIH , verbatim from source
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GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 686 changes logged to date.

What changed

The ClinicalTrials.gov registration describes a Phase 1 dose-escalation study investigating autologous CAR T cell therapy targeting both EGFR and IL13Rα2 tumor antigens in patients with recurrent high-grade gliomas. The trial employs locoregional delivery through an intracranial catheter, distinguishing this approach from systemic CAR T cell administration. Participating patients will undergo leukapheresis, T cell collection, genetic modification, and reinfusion following conditioning regimens.

For clinical operations and oncology programs, this trial represents an early-stage investigation into a dual-targeted CAR T approach for one of the most treatment-resistant malignancies. Institutions with glioblastoma programs or cell therapy capabilities may wish to monitor enrollment status and preliminary safety data as the study progresses.

Archived snapshot

Apr 22, 2026

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

Phase 1 NCT07544992 Kind: PHASE1 Apr 22, 2026

Abstract

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: Recurrent Astrocytoma, IDH-Mutant, Grade 4, Recurrent Glioblastoma, IDH-Wildtype

Interventions: Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells, Biopsy Procedure, Biospecimen Collection, Echocardiography Test, FDG-Positron Emission Tomography, Intracranial Catheter Placement, Leukapheresis, Magnetic Resonance Imaging, Resection

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Last updated

Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Pharmaceutical companies
Industry sector
3254 Pharmaceutical Manufacturing 6211 Healthcare Providers
Activity scope
Clinical trial participation Cell therapy administration Oncology research
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Public Health

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