On March 1, 2019 CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, reported that one of its leading drug candidates, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell for the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM), has received Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) (Press release, Carsgen Therapeutics, MAR 1, 2019, View Source [SID1234533883]).

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"At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December 2018, our collaborator, Dr. Songfu Jiang presented encouraging safety and efficacy data in patients with rrMM who received CT053 BCMA-CAR-T cells. The IND clearance of BCMA-CAR-T cells by China’s NMPA is of great significance to CARsgen," said Dr. Zonghai Li, founder, CEO and CSO of CARsgen. "According to JAMA Oncology, in 2016, there were about 130,000 cases of myeloma, which means from 1990 to 2016, incident cases of myeloma increased by 126% globally[1] and despite the development of novel therapies, multiple myeloma remains incurable and new treatment options are needed. As part of the CT053 development plan, we also intend to submit an IND application for BCMA-CAR-T cells to the U.S. FDA in 2019. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."