What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells, Biopsy Procedure, or Biospecimen Collection. The registry lists allocation as na. 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).
They plan to enroll about 24 people at Duarte. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.
Official title (unrewritten)
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)
Interventions: 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
Primary outcome (registry wording): Incidence of adverse events