eligibility_summary
Eligibility: Consent, advanced gynecologic cancer (cervical/ovarian/endometrial/others) progressed after or unsuited to 1st-line, ECOG 0–1, ≥1 non-irradiated lesion without prior local therapy yielding ≥1 g tissue for TIL prep. Exclude: unresolved cord compression, uncontrolled pain, major bleeding risk, interstitial/active pneumonia or severe lung disease, active/recent autoimmune disease or immunosuppression, allergies (TILs, Cy, Flu, IL‑2, DMSO, HSA, dextran‑40, beta‑lactams, gentamicin), pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial tests GT201, an autologous tumor-infiltrating lymphocyte (TIL) cell therapy, with lymphodepleting chemotherapy (cyclophosphamide + fludarabine) and interleukin-2 (IL‑2) support in advanced gynecologic cancers. Drug types/mechanisms: GT201 is a biological cell therapy of ex vivo–expanded patient T cells enriched for tumor reactivity, they recognize tumor antigens via TCRs and kill via perforin/granzyme and cytokines. Cyclophosphamide (small-molecule DNA-alkylating agent) and fludarabine (small-molecule purine analog) deplete endogenous lymphocytes, including Tregs, to create “space” and increase homeostatic cytokines, enhancing TIL engraftment. IL‑2 (cytokine/biologic) promotes T-cell activation, proliferation, and persistence via IL‑2R/JAK‑STAT signaling. Targets: tumor cells in cervical/ovarian/endometrial cancers, immune targets include CD8+/CD4+ TILs, TCR signaling, IL‑2 pathway, and depletion of host lymphocytes/Tregs.