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    Home > Medical News > Latest Medical News > Keji biological all human bcma-car t in the treatment of multiple myeloma has been approved by the US FDA clinical trial

    Keji biological all human bcma-car t in the treatment of multiple myeloma has been approved by the US FDA clinical trial

    • Last Update: 2019-06-20
    • Source: Internet
    • Author: User
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    June 19, 2019 / AP / -- car-t cell immunotherapy R & D enterprise carsgen therapeutics (Shanghai) Co., Ltd today announced that the company independently researched and developed the product under development - ct053 all human anti BCMA auto cart cell injection for the treatment of relapsed refractory multiple myeloma clinical trial (ind) application, which has received the US national food and drug administration Notice of FDA approval for the product to enter clinical trials Ct053car-bcmat is an innovative drug independently developed by Keji biology It is a T cell modified by the chimeric antigen receptor (car) targeting B cell mature antigen (BCMA) with all human antibodies The main target indication is relapsed / refractory multiple myeloma The clinical trial was approved in the United States, which is the second national or regional clinical license for the product after it was implicitly approved by the National Drug Administration (nmpa) on February 27, 2019 This approval is also the first time for China's original car-t project to independently apply for ind in the United States, and successfully obtained FDA approval "According to JAMAOncology, there are about 13 new cases of multiple myeloma in 2016, which means that the incidence rate increased from 126%[1] to 126%[1] in 1990 to 2016," said Dr Although there are some new treatment methods, multiple myeloma is still difficult to cure, still need more advanced and effective treatment methods Since the December 2018 annual meeting of American hematology, we first reported the encouraging results of safety and effectiveness of ct053 all human anti bcmacart cells in the treatment of relapsed / refractory multiple myeloma patients At the fifth multiple myeloma seminar held in Denver, USA in May 2019, the updated data of the project showed that as of February 28, 2019, in 24 patients with relapsed / refractory multiple myeloma The overall remission rate (ORR) and complete remission rate of patients with myeloma were 87.5% and 70.8%, respectively It is of great significance to obtain the clinical trial license from FDA We sincerely hope that ct053car-bcmat cells can promote the registration of clinical trials in China and the United States as soon as possible to save and benefit more patients with advanced multiple myeloma " Reference: [1] jamaoncol.2018; 4 (9): 1221-1227.doi: 10.1001/jamaoncol.2018.2128 About Keji biological science and technology biomedical (Shanghai) Co., Ltd., it is a biomedical enterprise dedicated to the development of innovative cancer immunotherapy drugs such as cart cells to provide treatment and even cure means for cancer patients The company has developed a number of cart cell candidate drugs, and has cooperated with famous Chinese hospitals and doctors in a number of exploratory clinical studies on cart cell therapy for liver cancer, gastric cancer, pancreatic cancer, multiple myeloma, lymphoma, leukemia, lung cancer, etc.
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