TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma
brief summary
This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients.
detailed description
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.
official title
A Phase 1, Open-label, Single-arm Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of TNFa and IL-2 Coding Oncolytic Adenovirus TILT-123 in Combination With Lymphocyte-depleting Chemotherapy and Tumor-infiltrating Lymphocytes in Melanoma Patients.