Development of safety assessment system using primate model for practical use of genetically modified T cells

Abstract

We have established the first open laboratory in Japan to conduct nonclinical safety research in primates for the practical use of genetically modified cells as a part of an AMED development project. We conducted a preliminary toxicity study of new CAR-T cells by producing novel CAR-T from the peripheral blood of cynomolgus monkeys and administering it to donor animals. As a result, new CAR-T cells were detected in all animals, but no appreciable toxicological findings were noted. These results demonstrate the potential use of primate autologous models in assessing the toxicity of CAR-T cells.