eligibility_summary
Eligible adults (≥18) with Karnofsky >60% and histologically/cytologically confirmed recurrent/metastatic squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx) who provide informed consent/HIPAA. Exclude those with severe heart disease (CHF, CAD, uncontrolled HTN/arrhythmia, MI <6 mo), stroke/TIA <12 mo, or severe hypersensitivity to cyclophosphamide or fludarabine.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: iC9.CAR‑CSPG4 autologous CAR‑T cells (gene‑modified T‑cell therapy) plus lymphodepletion with cyclophosphamide and fludarabine. Mechanisms: CAR‑T cells are engineered T lymphocytes expressing a chimeric antigen receptor specific for chondroitin sulfate proteoglycan‑4 (CSPG4), upon antigen binding they activate and kill CSPG4+ tumor cells (HLA‑independent) via cytotoxic effector pathways. The construct includes an inducible caspase‑9 (iC9) safety switch enabling on‑demand CAR‑T ablation if severe toxicity occurs. Cyclophosphamide (alkylating agent) and fludarabine (purine analog) induce lymphodepletion to enhance CAR‑T expansion/engraftment. Targets: CSPG4 on HNSCC cells, host lymphocytes (for depletion).