eligibility_summary
Eligibility: Adults 18–65 with advanced HPV16+ solid tumors (e.g., cervical, nasopharyngeal [EBV–], head & neck SCC) after failing standard therapy (≥2nd‑line, NPC ≥3rd‑line), not amenable to surgery/radiation, HLA‑A02:01, ECOG 0–1, life ≥3 mo, measurable disease, consent, women: negative test + contraception. Exclude: prior gene‑modified T cells, recent therapy/T‑cell immunomodulators, poor organ function, serious comorbidities or cardiac disease (LVEF<50), brain mets, MDS/lymphoma, autoimmune/immunodeficiency, HBV/HCV/HIV/syphilis, pregnancy/lactation, or per PI.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: CRTE7A2-01 TCR-T cells (autologous, gene-modified adoptive cell therapy) plus lymphodepleting chemotherapy (fludarabine, cyclophosphamide) and IL-2. Mechanisms: Patient T cells are engineered to express a T-cell receptor specific for an HPV16 E7 peptide presented by HLA-A02:01. After infusion, these TCR-T cells recognize E7–HLA complexes on tumor cells and mediate cytotoxic killing (perforin/granzyme). Fludarabine/cyclophosphamide deplete lymphocytes and Tregs to enhance engraftment, IL-2 supports T-cell expansion/persistence. Targets: HPV16+ tumor cells (cervical, anal, head/neck, other) expressing E7 with HLA-A02:01, pathways include MHC I antigen presentation, TCR signaling, and effector CTL activity.