CARsgen Therapeutics Receives No Objection to Clinical Trial Application from Health Canada for CT053-MM-02, BCMA-CAR-T Cell Therapy for rrMM

发布时间: 2019年7月4日

SHANGHAI, July 4, 2019 / -- CARsgen Therapeutics, a clinical-stage company committed to developing Chimeric Antigen Receptor T cell therapies for cancer, today announced it received a No Objection Letter from Health Canada on July 3 providing clearance to proceed with sites in Canada for the Company’s Phase 1b clinical trial of leading drug candidate CT053. The CT053 product is a fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell therapy for the treatment of patients suffering from relapsed/refractory multiple myeloma. CT053 has also received IND clearance from the National Medical Products Administration (NMPA) in China in Feb 2019 and the United States Food and Drug Administration (FDA) in June 2019. CT053 is the subject of an ongoing phase I clinical trial.

"At the 5th Annual Immunotherapy in Myeloma Scientific Workshop in Denver, Colorado, CARsgen provided an update of the clinical data of CT053 and showed that as of Feb. 28, 2019, 87.5% of the patients showed overall response to the treatment. 70.8% of the patients had complete response and no grade 3 or higher cytokine release syndrome (CRS) was observed in 24 heavily pre-treated patients with rrMM. The IND clearance of CT053 by the U.S. FDA is of great significance to patients" 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 therapiesmultiple myeloma remains incurable and new treatment options are needed. Our goal is to continue the development of novel, safe and effective immunotherapies. This is our long-standing commitment to cancer patients worldwide."


[1] JAMA Oncol. 2018;4(9):1221-1227. doi: 10.1001/jamaoncol.2018.2128.

About CARsgen Therapeutics

CARsgen Therapeutics is a clinical-stage immune-oncology company committed to the development and commercialization of CAR-T therapeutics for unmet medical need. The company has collaborated with top hospitals in China to launch several First-in-Human studies such as CAR-GPC3-T for hepatocellular carcinoma and squamous lung cancer, CAR-EGFR/EGFRvIII-T for glioblastoma multiforme and CAR-Claudin18.2-T for gastric and pancreatic cancer.

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SOURCE CARsgen Therapeutics Co. Ltd.

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