eligibility_summary
Key eligibility: 18–75, measurable recurrent/metastatic solid tumor, HLA-A02:01, HPV16+, failed/intolerant to 1st-line, venous access, ECOG 0–1, >6-mo life expectancy, contraception, negative pregnancy test, negative HIV/HBV DNA/HCV, adequate blood counts/chemistry/coagulation, LVEF ≥50%, ≥4 wks since last therapy, toxicities ≤G1. Exclude: pregnancy/lactation, severe allergy, transplant, brain mets, active autoimmune/infections, major organ/CV/resp disease, recent steroids/immunomodulators, other cancer, noncompliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase 1, single-arm study in China testing HPV-T (autologous adoptive T-cell therapy) plus interleukin-2 in HLA-A0201, HPV-16–positive recurrent/metastatic solid tumors. HPV-T comprises patient-derived T cells expanded to recognize HPV-16 E6/E7 oncoproteins, mechanism: TCR-mediated recognition of E6/E7 peptides presented on MHC class I (HLA-A0201) on tumor cells, triggering cytotoxic killing. IL-2 (cytokine drug) is administered subcutaneously post-infusion to support T-cell survival, proliferation, and function via IL-2 receptor signaling. Dosing: 5×10^9 or 1.5×10^10 cells IV per infusion, up to 4 cycles, IL-2 500,000 IU/m^2 every 8–12 hours for up to 6 doses after each infusion. Targets: HPV-16–expressing tumor cells (E6/E7), pathways: TCR–MHC I antigen recognition, CD8+ T-cell cytotoxicity, and IL-2–driven expansion.