Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma

Summary

This phase I trial tests the safety, side effects and best dose of TGFβR2KO/IL13Rα2 chimeric antigen receptor (CAR) T-cells given within the skull (intracranial) in treating patients with glioblastoma or IDH-mutant grade 3 or 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). 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. When the cells are taken from the patient's own blood, it is known as autologous. Then the gene for special receptors that bind to a certain proteins on the patient's tumor cells are added to the T cells in the laboratory. The special receptors are called CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving TGFβR2KO/IL13Rα2 CAR T cells may be safe, tolerable, and/or effective in treating patients with recurrent or progressive glioblastoma or grade 3 or 4 IDH-mutant astrocytoma.

Conditions

• Recurrent Astrocytoma, IDH-Mutant, Grade 3
• Recurrent Astrocytoma, IDH-Mutant, Grade 4
• Recurrent Glioblastoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo CSF and blood sample collection

BIOLOGICAL

Chimeric Antigen Receptor T-Cell Therapy

Given autologous TGF-betaR2KO/IL13R-alpha2-CAR T cells intracranially

PROCEDURE

Echocardiography

Undergo echocardiography

OTHER

Fludeoxyglucose F-18

Undergo FDG-PET

PROCEDURE

Intracranial Catheter Placement

Undergo placement of Rickham catheter

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET

PROCEDURE

Resection

Undergo surgical resection

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

2025-06-17

Primary Completion

2030-10-11

Completion

2030-10-11

FDA Drug

Yes

Countries

• United States

Study Locations