eligibility_summary
Eligible: patients with HPV16/52-positive squamous cell carcinoma (cervical, head/neck, anal, penile, vulvar, vaginal) that is advanced/metastatic and progressed after ≥1 systemic therapy, HLA-A02:01, RECIST-measurable disease, ECOG 0–1, life expectancy ≥3 months, adequate labs. Exclude: CNS disease/metastases, other cancer <2y, organ transplant, HIV/AIDS, active cardiac/pulmonary/autoimmune disease, poor venous access, prior cell therapy, allergy to LD chemo/SCG142, serious condition or lab abnormality.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: SCG142 (autologous, gene‑modified TCR T‑cell therapy, biological) given after lymphodepletion with cyclophosphamide (alkylating small‑molecule chemotherapeutic) and fludarabine (purine analog small‑molecule chemotherapeutic). Mechanisms: SCG142 T cells are engineered to express an HLA‑A02:01–restricted TCR that recognizes HPV16/52‑derived tumor antigens and, upon engagement, trigger antigen‑specific cytotoxicity and cytokine release to kill HPV+ tumor cells. Cyclophosphamide/fludarabine deplete host lymphocytes (including Tregs), reduce cytokine sinks, and promote SCG142 expansion/persistence. Targets: HPV16/52 antigen–expressing squamous carcinoma cells via MHC class I (HLA‑A02:01), activating adaptive T‑cell cytotoxic pathways.