eligibility_summary
Inclusion: adults 18–70, ECOG 0–1, ≥12-week survival, advanced head & neck cancer without options, Trop2+ tumor (≥2+, ≥40%), RECIST-measurable lesion, venous access, adequate organ function, contraception/negative pregnancy. Exclusion: recent therapy/vaccine/surgery, prior Trop2/CAR/TCR/cell tx, CNS mets, active infection, viral/TP/HIV positives, autoimmunity/immunodeficiency, steroids, unresolved AEs, lung disease, severe CV/CVA, allergies, other cancers/transplant, fluid overload, pregnancy/breastfeeding, psych, investigator discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06614686 (Phase 1, single-arm, open-label) in advanced head and neck cancers (including nasopharyngeal), China. Intervention: U87 autologous CAR-T cell therapy (cellular gene therapy/immunotherapy). Patients undergo leukapheresis, lymphodepleting preconditioning, then U87 infusion, dose escalation/expansion. Target/mechanism: U87 CAR-T cells are engineered T lymphocytes expressing a chimeric antigen receptor specific for Trop-2 (TACSTD2). Binding to Trop-2 on tumor cells triggers T-cell activation, cytokine release, and cytotoxic killing of Trop-2–positive cancer cells. Targeted cells/pathways: Trop-2–expressing malignant epithelial cells in head/neck tumors, engagement of T-cell receptor signaling via CAR (CD3ζ with costimulation) to drive tumor cell lysis. Trop-2 positivity (IHC ≥2+, ≥40%) required. Primary focus: safety, tolerability, preliminary efficacy.