eligibility_summary
Inclusion: ≥18, ECOG 0–1, unresectable stage III/IV cutaneous melanoma progressed after PD-(L)1 (and BRAF/MEK if BRAFV600), accessible lesion for TIL harvest, measurable disease, adequate organ function, contraception/negative pregnancy test. Exclusion: LDH ≥2×ULN, life expectancy ≤3 mo, unresolved toxicities, uveal/mucosal melanoma, active/new CNS mets or steroids ≥10 mg, autoimmune/immunodeficiency/infection, major cardiac/QTc>470, recent cancers, pregnancy, uncontrolled HBV/HCV/HIV, live vaccine ≤30 d, COVID-19+, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase I single-arm study in advanced melanoma testing two immunotherapies. 1) Autologous tumor-infiltrating lymphocyte (TIL) adoptive cell therapy (cellular therapy): patient-derived, ex vivo–expanded T cells infused after preparative chemotherapy, mechanism—tumor antigen–specific TCR recognition and cytotoxic killing, aims to repopulate with highly tumor-reactive T cells. 2) ANV419 (biologic cytokine): an engineered IL‑2 variant that selectively stimulates IL‑2 receptor β/γ (CD122/CD132) while sparing IL‑2Rα (CD25), mechanism—drives JAK/STAT signaling to expand/activate effector CD8+ T cells and NK cells, minimizing Treg expansion and IL‑2–related toxicity, given IV on day 0 and 14 to boost in‑vivo TIL expansion. Targets: tumor-reactive TILs, CD8+ T cells, NK cells, pathways: TCR-mediated cytotoxicity, IL‑2/IL‑2Rβγ–JAK/STAT signaling, reduced Treg (CD25high) engagement.