Expert guidance for clinical research of genetically engineered T cells (2021)
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Abstract:
[Abstract] Clinical research on genetically engineered T cells has been carried out in China; however, there is no professional guidance for doctors to manage the treatment in such clinical research. Therefore, the Committee of Quality Control and Research of Cell Therapy, China Quality Association for Pharmaceuticals focuses on the specialty of clinical research of genetically engineered T cells, and organizes experts in the field to integrate the latest research progress and clinical practices, aiming to provide advices and suggestions on the selection of patients, the collection and preparation of cells, the storage and transportation of cells, as well as give recommendations on the clinical treatment before and after infusion and the evaluation of curative effects. After several rounds of discussion and revision, the Expert Guidance for Clinical Research of Genetically Engineered T Cells (2021) is finally formulated. This guidance aims to provide recommendations for clinical researchers and guard the safety and benefits of patients to the largest extent.
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Project supported by the National Key Research and Development Program of China (No. 2018YFC1313400)and the National Science and Technology Major Projects for “Major New Drugs Innovation and Development ” of China (No.2020ZX09201-009)