Abstract
In March 2019, the first chimeric antigen receptor-T cell （CAR-T cell） therapy, tisagenlecleucel （Kymriah®, Novartis）, was approved in Japan. Tisagenlecleucel is indicated for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia （B-ALL） and relapsed or refractory CD19-positive diffuse large B-cell lymphoma （DLBCL）. Tisagenlecleucel is a living drug generated from patient’s own T cells. Leukapheresis is an important step, which in turn, T cells are genetically reprogrammed by a lentivirus vector encodes chimeric antigen receptor （CAR） gene. The approval of tisagenlecleucel is based on the results of an international multicenter phase II study （ELIANA, JULIET） for relapsed or refractory CD19-positive B-ALL and DLBCL. This CAR-T cell therapy requires not only advanced manufacturing but also a quality management system.
