Definition

A preparation of cytotoxic, autologous effector cells specifically targeted towards tumor cells and comprised primarily of natural killer (NK) cells, CD56+ NK T cells (NKTs), CD8+ T-cells and gamma delta T cells stored in cryogenic media, with potential immunomodulating and antineoplastic activities. The autologous effector cells are prepared by collecting peripheral blood mononuclear cells (PBMCs) from cancer patients, which are stimulated with the induction reagent engineered leukocyte immunostimulatory (ENLIST) cells to activate and differentiate the PBMCs; the activated cells are expanded with cytokines, and the tumor killing effector cells, including NK cells, CD8+ T cells, TCRgd T cells, NKT cells and some CD4+ T cells, are cryopreserved. Upon intravenous re-administration into the patient, the autologous PBMC-derived ENLIST cells-activated effector cells recognize and induce an immune-mediated killing of tumor cells. ENLIST cells are engineered SK-MEL2 melanoma cell lines (APX-DC and APX-L) that express immunomodulatory proteins that are engineered for membrane expression and contain endogenous tumor-associated antigens (TAAs).