2021-01-19 06:41:02 GRCL Gracell
01/19/21 01/1906:41 01/19/2106:41 | Gracell's IND for acute lymphoblastic leukemia therapy approved in ChinaGracell Biotechnologies announced that the National Medical Products Administration in China has approved an investigational new drug application to study GC019F, a FasTCAR-enabled chimeric antigen receptor-T therapy in patients with relapsed or refractory adult B-cell acute lymphoblastic leukemia. GC019F is an autologous CAR-T therapy currently in development for adult B-ALL patients who are relapsed from or refractory to prior therapies. With the therapy, a patient's own T cells are genetically modified to express CD19-specific CAR. GC019F is manufactured on Gracell's FasTCAR technology platform, which significantly reduces manufacturing time from an industry norm of two to six weeks down to 22 to 36 hours. GC019F is an autologous investigational CD19-targeted CAR-T cell therapy, directed to eradicate CD19 positive leukemia cells. B-ALL, a major form of acute lymphoblastic leukemia, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50. In 2015, ALL affected around 837,000 people globally |
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