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On May 28, the CDE official website announced that Reindeer Bio submitted two clinical trial applications for Iquilenx injection, which were accept.
Screenshot source: CDE official website
Screenshot source: CDE official websiteThis is the first clinical trial application submitted in China for CAR-T cell therapy for the treatment of autoimmune diseases, and the world's first clinical trial application for CAR-T treatment of neuromyelitis optica spectrum diseas.
According to public information, CT103A is an innovative BCMA-targeting CAR-T product candidate jointly developed by Reindeer Bio and Innovent B.
This time, the clinical trial application submitted by CT103A is for a new indication, neuromyelitis optica spectrum disorder (NMOS.
This new indication application is based on a clinical study (Investigator Initiated Trial, IIT) initiated by the investigator of Iquilenza Injecti.
The research data preliminarily show that the 5×106 CAR-T cells/kg and 0×106 CAR-T cells/kg dose groups of Iquilenxe injection have shown a more reliable performance in the treatment of NMOSD subjects that are poorly controlled by traditional thera.
Reference source: Pharmaceutical Guanlan, PR Newswire
Reference source: Pharmaceutical Guanlan, PR Newswire