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

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.

Conditions

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

Interventions

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Resection

Undergo surgical resection

PROCEDURE

Intracranial Catheter Placement

Undergo ICT and/or ICV catheter placement

BIOLOGICAL

Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells

Given via ICT and/or ICV catheter

PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood, TCF, and CSF sample collection

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

FDG-Positron Emission Tomography

Undergo FDG-PET

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Behnam Badie · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-12-24

Primary Completion

2031-11-04

Completion

2031-11-04

FDA Drug

Yes

Countries

• United States

Study Locations