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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.

Participant has not yet recovered from toxicities of prior therapy.

Participant has received any live vaccine within 30 days prior to enrollment.

Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.

Trial design

Treatments tested in this trial

  • 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

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator