eligibility_summary
Include: 18–75, advanced solid tumor, ≥1 resectable lesion for TIL + ≥1 measurable (RECIST), not locally treated in past 28 d or progressed, ECOG 0–1, OS >3 mo, adequate organs, tox ≤G1, contraception, consent. Exclude: allergy, uncontrolled CV/metabolic disease or CV events, immunosuppressants/anti‑tumor ≤4 wk, HIV or active HBV/HCV/TB, COVID vax ≤4 wk or live vax ≤3 mo, major surgery ≤4 wk, severe pulm/GI disease, uncontrolled CNS mets, active autoimmune disease on systemic tx, prior cell tx, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: HS-IT101, an autologous tumor-infiltrating lymphocyte (TIL) adoptive cell therapy (5×10^9–6×10^10 cells i.v.), given after lymphodepleting chemotherapy (fludarabine + cyclophosphamide) and followed by recombinant human IL-2. Mechanisms: TILs are ex vivo–expanded patient-derived cytotoxic T cells that recognize tumor neoantigens via TCR–MHC and kill tumor cells through perforin/granzyme and IFN-γ. Fludarabine (purine analog antimetabolite) and cyclophosphamide (DNA-alkylating agent) deplete host lymphocytes (including Tregs), reduce cytokine sinks, and enhance TIL engraftment. IL-2 (cytokine biologic) promotes T-cell activation, proliferation, and persistence via IL-2R/JAK-STAT. Targets: tumor cells presenting neoantigens, TCR-mediated cytotoxicity, IL-2 signaling, depletion of endogenous lymphocytes/Tregs. Phase I, single-arm in advanced solid tumors.