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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells — BIOLOGICAL
  Given via ICT and/or ICV catheter
• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood, TCF, and CSF sample collection
• Echocardiography Test — PROCEDURE
  Undergo ECHO
• FDG-Positron Emission Tomography — PROCEDURE
  Undergo FDG-PET
• Intracranial Catheter Placement — PROCEDURE
  Undergo ICT and/or ICV catheter placement
• Leukapheresis — PROCEDURE
  Undergo leukapheresis
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Resection — PROCEDURE
  Undergo surgical resection

Study Details

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.

Key Dates

Start date

Dec 24, 2026

Status verified

May 2026

Primary completion

Nov 4, 2031

Completion

Nov 4, 2031

Study Design

Enrollment

24 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (EGFR/IL13Rα2 pool-CAR T cell therapy)
  Patients undergo leukapheresis followed by surgical resection, biopsy, and ICT and/or ICV catheter placement 1-3 weeks prior to cycle 1, day 0. Patients then receive EGFR/IL13Rα2 pool-CAR T cells via ICT and/or ICV catheter over 5 minutes on day 1 of each cycle. Cycles repeat every 7 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may receive additional cycles of EGFR/IL13Rα2 pool-CAR T cells per PI and patient discretion and/or undergo additional leukapheresis as needed on study. Patients also undergo ECHO during screening, as well as FDG-PET, MRI, and blood, TCF, and CSF sample collection throughout the study.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 15 years ]

Locations (1)

Find similar trials in Duarte, CA

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