eligibility_summary
Adults ≥18, KPS ≥70, EGFRvIII+ GBM. Cohort 1: CLIA NGS-confirmed, MGMT unmethylated/MI<3, post-SOC EBRT, E‑SYNC ≤12 wks post‑EBRT. Cohort 2: H‑score ≥250, Step 2 needs RANO PD and resectable recurrence (≥500 mg). Labs/organ OK: ANC ≥1000, Plt ≥100k, ALC ≥300/CD3 ≥150, CrCl ≥50, bili ≤1.5×ULN, AST/ALT ≤3×, LVEF ≥40, O2 sat >92, off systemic steroids ≥3 d. Exclude: recent therapy, prior EGFR‑Rx, LMD, active HBV/HCV, HIV/IS, transplant, mass effect, pregnancy, uncontrolled illness/addiction.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06186401 tests E-SYNC, an autologous gene‑modified T‑cell therapy (cellular immunotherapy). Patient T cells are engineered with an anti‑EGFRvIII synNotch receptor that, upon engagement with EGFRvIII on tumor cells, induces expression of a CAR targeting EphA2 and IL‑13Rα2. This logic‑gated design aims to confine CAR activation to EGFRvIII+ glioblastoma, enhancing specificity and reducing off‑tumor activity. Interventions: E-SYNC T cells (IV infusion after leukapheresis) following lymphodepleting chemotherapy with cyclophosphamide (alkylating agent) and fludarabine (purine analog antimetabolite) to improve CAR T expansion/engraftment. Targets/pathways: EGFRvIII (mutant EGFR signaling), EphA2 (RTK), IL‑13Rα2, effector cells are autologous T cells engaging tumor antigen pathways in GBM. Primary aim: safety/dose finding.