A Phase 1 Trial to Evaluate the Safety of EGFR/IL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)
City of Hope Medical Center
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.
Description
PRIMARY OBJECTIVE: I. Assess the safety and determine the maximum tolerated dose (MTD) of locoregional administration of autologous anti-EGFR/anti-IL13Rα2 CAR T-cells (EGFR/IL13Rα2 pool-CAR T cell) therapy. SECONDARY OBJECTIVES: I. In participants who receive at least 50% of the assigned cell dose for each cycle (1-4) and at least 70% of the total cumulative dose: 1. Estimate disease control rate (DCR: complete response \[CR\] + partial response \[PR\] +stable disease \[SD\]); 2. Estimate overall response rate (ORR: CR+PR); 3. Estimate time to progression (TTP); 4. Estimate median overall…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Main Inclusion Criteria * Documented informed consent of the participant and/or legally authorized representative. * 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. * Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression c…
Interventions
- BiologicalAutologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells
Given via ICT and/or ICV catheter
- ProcedureBiopsy Procedure
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo blood, TCF, and CSF sample collection
- ProcedureEchocardiography Test
Undergo ECHO
- ProcedureFDG-Positron Emission Tomography
Undergo FDG-PET
- ProcedureIntracranial Catheter Placement
Undergo ICT and/or ICV catheter placement
- Procedure
Location
- City of Hope Medical CenterDuarte, California