eligibility_summary
Inclusion: consent, unresectable recurrent/metastatic solid tumor, ≥1 resectable, previously untreated lesion providing ≥1.0 cm3 tissue for TIL. Exclusion: active/untreated CNS mets (unless ≤3, <1 cm, no edema, stable ≥3 mo), autoimmune disease or systemic steroids/immunosuppression (>10 mg prednisone), thrombotic event ≤3 mo, refractory epilepsy, uncontrolled effusions, GI bleed, IL-2 contraindication, other trials ≤4 wk, prior allogeneic transplant, drug hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT06145802 tests GT316, an autologous tumor‑infiltrating lymphocyte (TIL) infusion for advanced solid gynecologic tumors. Drug/Interventions and mechanisms: 1) GT316 (cellular immunotherapy): patient-derived, ex vivo–expanded T cells (polyclonal TILs) that recognize tumor neoantigens via the TCR and kill tumor cells through perforin/granzyme and IFN-γ–mediated cytotoxicity. 2) Lymphodepleting chemo (non‑myeloablative, low‑dose cyclophosphamide + fludarabine): reduces host lymphocytes (including Tregs) to improve TIL engraftment, cyclophosphamide alkylates DNA, fludarabine inhibits DNA synthesis (purine analog). 3) IL-2 support: cytokine that promotes T-cell survival/expansion via IL-2R signaling. Targets: tumor cells presenting patient-specific antigens (HLA/MHC), host immune compartment (lymphodepletion), and IL‑2 pathway for TIL expansion. Single-arm dose-escalation/expansion.