Abstract
We performed a single-arm exploratory clinical trial that is ongoing and registered at ClinicalTrials.gov (NCT03093688). Patients were infused with autologous iNKT cells, PD-1 + CD8+ T cells, and dendritic cells every 3-5 weeks, which was considered 1 cycle. The primary endpoints were safety and objective tumor response. The preliminary results from the first three patients are reported here. The first patient received 16 cycles. Computed tomography (CT) examination revealed a stable disease (SD) response after 4 cycles and progressive disease (PD) response after 11 cycles. For the second patient that received 10 cycles, CT examination revealed an SD response after 4 cycles and a PD response after 9 cycles. For the third patient who was treated with 6 cycles, CT examination revealed an SD response after 4 cycles. The patients suffered from only grade 1-2 adverse events. iNKT cell and PD-1 + CD8+ T cell-based immunotherapy showed a manageable tolerability profile.