eligibility_summary
Eligible: 18–75, metastatic solid tumor after failure/intolerance of standard therapy, resectable lesion (≥15 mm or core biopsy) plus measurable lesion (RECIST 1.1), ECOG 0–1, life expectancy ≥3 mo, adequate organs/coagulation, LVEF ≥50% or NYHA I, FEV1 ≥75%. Exclude: prior organ/cell therapy, drug hypersensitivity, active CNS mets, serious illness, active HIV/HCV RNA+/HBV/syphilis, immunodeficiency or steroids >10 mg, other cancers <3 y, live vaccine <28 d, prior severe immune AEs, pregnant/lactating, unresolved >G1 AEs, no contraception, urgent disease/unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Interventions: BEN101 (autologous tumor-infiltrating lymphocyte, TIL, adoptive cell therapy, cellular biologic), given after non‑myeloablative lymphodepletion (cyclophosphamide—alkylating agent, fludarabine—purine analog antimetabolite, paclitaxel—microtubule stabilizer chemotherapeutic) and followed by high‑dose IL‑2 (cytokine biologic). Mechanisms of action: Ex vivo–expanded autologous TILs mediate antigen-specific tumor killing via TCR recognition of peptide–MHC on tumor cells and cytotoxic effector functions (perforin/granzymes, cytokines). IL‑2 drives TIL proliferation/survival and activation via IL‑2R/JAK‑STAT5 signaling. Lymphodepletion reduces endogenous lymphocytes (incl. Tregs) and cytokine sinks, enhancing homeostatic cytokines (IL‑7/IL‑15) and TIL engraftment. Cells/pathways targeted: Effector CD8+/CD4+ T cells, tumor cells via TCR–MHC, IL‑2 signaling, and depletion of immunosuppressive lymphocytes.