TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma

TILT-123 is a tumor-selective replicating oncolytic adenovirus expressing TNFa and IL-2 that is being investigated in several Phase 1 clinical studies in patients with various types of cancer. This is the second study of TILT-123 in patients with metastatic melanoma. Building upon the previous study, TILT-T215, which evaluated the safety and preliminary efficacy of TILT-123 in combination with TILs, Study TILT-T216 will investigate the addition of lymphocyte-depleting chemotherapy to the combination of TILT-123 and TILs. The purpose of lymphodepleting chemotherapy, cyclophosphamide and fludarabine phosphate is to reduce irrelevant T cells and eliminate the regulatory T cells, which are known to be able to inhibit T-cell mediated tumor cell killing.