eligibility_summary
Adults 18–75 with advanced solid tumors after ≥1 prior line, ECOG 0–1, >3‑mo survival, ≥1 resectable lesion for TIL and a RECIST‑measurable target, adequate organ function, prior toxicities ≤G1, contraception. Exclude: drug hypersensitivity, uncontrolled CV/metabolic disease or recent major CV events, active autoimmune on systemic therapy, prior transplant/immunosuppression, recent therapy/vaccines/surgery, active infections (HIV, HBV/HCV, TB), severe lung/GI disease, uncontrolled CNS mets, prior similar cell therapy, pregnancy, serious psych/substance issues.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions and mechanisms: HS-IT201 Injection is an autologous tumor-infiltrating lymphocyte (TIL) adoptive cell therapy (cell therapy). Ex vivo–expanded, polyclonal CD8+/CD4+ TILs recognize patient-specific tumor antigens via native TCRs and kill tumor cells through cytotoxic granules and cytokines (e.g., IFN-γ). Preconditioning uses fludarabine (antimetabolite chemotherapeutic) and cyclophosphamide (alkylating chemotherapeutic) to lymphodeplete, reduce Tregs/cytokine sinks, and enhance TIL engraftment. Post-infusion recombinant IL-2 (cytokine biologic) supports TIL proliferation/survival via IL-2R–JAK/STAT signaling. Targets: tumor cells bearing endogenous antigens, immune pathways include TCR signaling, effector cytotoxicity, IL-2–driven expansion, and depletion of suppressive lymphocytes.