eligibility_summary
Adults ≥20. Manufacturing: ≥1 breast/lung lesion >1 cm imaged ≤3 months and planned tissue collection, consent. Infusion: unresectable advanced/metastatic breast or lung cancer with RECIST lesion, progressed/intolerant to standard therapy, pre‑TILs/NEOG‑100 feasible, ECOG 0–1, ≥12‑week survival, adequate labs, AEs resolved. Exclude: drug hypersensitivity, prior transplant/cell therapy, other active malignancy, serious CV/TE/resp disease, active CNS mets, severe infection, immune disorders, recent steroids/live vaccine/therapy, pregnancy/no contraception, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: NCT06107894 (Phase 1). Intervention: NEOG-100, an autologous tumor-infiltrating lymphocyte (TIL) cell therapy, infused IV after non-myeloablative lymphodepletion (cyclophosphamide—alkylating agent, fludarabine—purine analog). Cohort 2 adds low-dose IL-2 (aldesleukin), a cytokine biologic, given SC for 14 days. Mechanisms: TILs are expanded patient-derived cytotoxic T cells that recognize tumor neoantigens via TCR–MHC and kill tumor cells via perforin/granzyme and IFN-γ. IL-2 enhances T-cell proliferation, survival, and cytotoxic function through IL-2/STAT5 signaling. Lymphodepletion reduces endogenous lymphocytes/Tregs and boosts homeostatic cytokines (IL-7/IL-15) to improve TIL engraftment. Targets: tumor cells in advanced breast and lung cancers, immune pathways: TCR signaling, IL-2 axis, reduction of Tregs/immunosuppression.