eligibility_summary
Key inclusion: Able to understand and sign IRB/IEC-approved consent (patient or LAR). ≥1 resectable, previously untreated lesion (non-irradiated, no prior local therapy), preferably superficial nodes, yielding ≥1.0 g tissue (single or combined) for TIL prep, minimally invasive preferred. Key exclusion: Autoimmune disease or >10 mg/day prednisone, thrombotic event within 3 months, active systemic infection or fever >38.5°C, prior allogeneic transplant, allergy to TIL, cyclophosphamide, fludarabine, IL-2, DMSO, HSA, dextran-40, beta-lactams, gentamicin.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: GT201, an autologous tumor‑infiltrating lymphocyte (TIL) therapy (biologic, adoptive cellular immunotherapy) for advanced gynecologic/cervical cancer, with lymphodepleting chemotherapy (cyclophosphamide + fludarabine) and IL‑2 support. Mechanism: TILs expanded ex vivo from the patient are reinfused to recognize patient‑specific tumor antigens via T‑cell receptors, traffic to tumors, and kill malignant cells through cytotoxic granule release (perforin/granzyme) and cytokines (e.g., IFN‑γ), IL‑2 promotes in vivo expansion/persistence. Targets: antigen‑bearing tumor cells, key pathways include TCR signaling, CD8+ cytotoxic effector function, and IL‑2–driven homeostatic proliferation.