T-cell therapy in metastatic melanoma: TIL 1383I TCR transduced T cells after infusion and activity in vivo.

3043 Background: Studies in adoptive T-cell transfer have suggested that persistence of the transduced T-cells is central to the viability of this therapeutic option. The objectives of this phase I clinical trial using TCR TIL 1383I transduced T cells in stage IV melanoma patients include measuring of persistence and monitoring the behavior of tumor-reactive T-cells in vivo. Methods: Peripheral blood mononuclear cells (PBMCs) were isolated from three melanoma patients, activated with anti-hCD3 with rhIL2 and rhIL15, transduced with lentivirus encoding the TIL 1383I TCR, and expanded to treatment numbers. The transduced cells were suspended in 5% human albumin and infused over 30 minutes. The infusion was preceded by lymphodepletion with fludarabine and cyclophosphamide and followed with low dose IL-2 for one week. A modified CD34 cassette in the vector enabled monitoring of the transduced T cells in the patient’s PBMC post-infusion. PBMCs were collected from patients on days 1, 3, 5, 7, 14, 25, 35 and mon...