eligibility_summary
Adults 18–75, ECOG 0–1, survival >3 mo, metastatic/recurrent refractory solid tumors with ≥1 measurable lesion and tissue for TIL prep, adequate hematologic, liver/renal, and coag function, WOCBP use contraception to 24 wks post-dose. Exclude pregnancy/lactation, severe allergy, recent trials/surgery/live vaccines, other malignancy <5 y, CNS primary/metastasis, autoimmune/immunodeficiency (incl HIV), thromboembolism/bleeding/CV disease, active infections (TB, HBV/HCV/syphilis), prior cell therapy, IL‑2 contraindication, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
NCT05868915 (Phase I/II, single-arm) tests HV-101 for advanced solid tumors. Interventions: 1) HV-101: autologous, non–genetically modified tumor‑infiltrating lymphocyte (TIL) cell therapy, 2) Lymphodepleting chemotherapy: fludarabine (purine analog, DNA synthesis inhibitor) and cyclophosphamide (alkylating agent), 3) Post-infusion IL-2 (cytokine therapy). Mechanisms of action: HV-101 supplies ex vivo expanded tumor‑reactive T cells that recognize tumor antigens via TCRs and mediate cytotoxicity, fludarabine/cyclophosphamide deplete host lymphocytes (including Tregs) and reduce cytokine sinks to enhance engraftment, IL-2 promotes T-cell activation, proliferation, and survival. Cells/pathways targeted: tumor cells via TIL cytotoxicity, host lymphocytes/Tregs via conditioning, TCR-mediated adaptive immunity and IL‑2/JAK‑STAT5 signaling.