eligibility_summary
Adults ≥18 with recurrent IDH-wildtype GBM after radiotherapy (if MGMT-methylated: ≥12 wks post-RT), EGFR amplified, surgery/biopsy planned, adequate organ function (renal, hepatic, LVEF ≥45%, pulmonary reserve), KPS ≥60, contraception. Exclude: active infection incl HBV/HCV, NYHA III/IV, brainstem/spinal tumors, severe comorbidity, bevacizumab <3 mo, autoimmune on ≥10 mg prednisone or MS/Parkinsons, pregnant/nursing, allergy to HSA, DMSO, Dextran 40.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CART‑EGFR‑IL13Rα2 cells—an autologous, gene‑modified CAR T‑cell therapy delivered intrathecally. Construct: bicistronic lentiviral vector co‑expressing two CARs, a murine scFv to the cryptic EGFR 806 epitope and a humanized scFv to IL13Rα2. Mechanism of action: dual‑antigen binding activates CAR T cells, inducing cytokine release and cytotoxic killing of tumor cells, dual targeting aims to reduce antigen escape. Targets: glioblastoma cells with EGFR amplification/overexpression (EGFR 806 epitope) and cells expressing IL13Rα2. Pathways/cells affected: dysregulated EGFR signaling and IL13Rα2 pathways on GBM tumor cells, immune effector is activated T‑cell mediated cytotoxicity. Design: phase 1, 3+3 dose escalation with exploration of single vs two‑dose schedules.