| 细胞治疗产品安全性的研究进展 |
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| 引用本文： | 徐道俊,赵琼英,杨静雅,海杨昊,熊华清,周巧,古松海.细胞治疗产品安全性的研究进展[J].药物生物技术,2020(1):82-87. |
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| 作者姓名： | 徐道俊 赵琼英 杨静雅 海杨昊 熊华清 周巧 古松海 |
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| 作者单位： | 赛德特生物科技开发有限公司 |
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| 摘 要： | 目前肿瘤免疫治疗方案包括治疗性肿瘤疫苗、免疫检查点抑制剂(PD1、PDL1、CTLA-4)、过继性细胞免疫治疗(CAR-T、TCR-T、CAR-NK)、溶瘤病毒等,过继性免疫治疗技术主要是弥补经过主动免疫治疗(治疗性肿瘤疫苗、免疫检查点抑制剂)的无进展生存(PFS)的肿瘤人群。随着FDA批准的诺华和Kite细胞制品CAR-T的上市,国内外过继性细胞免疫治疗肿瘤的技术发展迅速,但是针对过继性细胞免疫治疗技术生产的细胞治疗产品的质量安全风险凸显出来。文章主要针对国内外细胞治疗产品质量安全性的研究进行综述。
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| 关 键 词： | 细胞治疗产品 过继性免疫治疗 质量控制策略 嵌合抗原受体T细胞(CAR-T) T细胞受体嵌合型T细胞(TCR-T) 病毒载体 |
Progress in the Study on the Safety of Cell Therapy Products |
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| XU Dao-jun,ZHAO Qiong-ying,YANG Jing-ya,HAI Yang-hao,XIONG Hua-qing,ZHOU Qiao,GU Song-hai.Progress in the Study on the Safety of Cell Therapy Products[J].Pharmaceutical Biotechnology,2020(1):82-87. |
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| Authors: | XU Dao-jun ZHAO Qiong-ying YANG Jing-ya HAI Yang-hao XIONG Hua-qing ZHOU Qiao GU Song-hai |
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| Institution: | (Cytocraft Biotech Development Co.,Ltd.,Kunming 650000,China) |
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| Abstract: | At present,tumor immunotherapy schemes include tumor vaccine,immunocheckpoint inhibitor(PD1,PDL1,CTLA-4),adoptive cellular immunotherapy(CAR-T,TCR-T,CAR-NK),tumor lytic virus and so on.The adoptive immunotherapy technique is mainly to make up for the non-progressive survival(PFS)population after active immunotherapy(tumor vaccine,immunospot inhibitor).With the listing of Novartis and Kite cell products CAR-T approved by FDA,the technology of adoptive cellular immunotherapy has developed rapidly at home and abroad,but the quality,safety and risk of cell therapy products produced by adoptive cellular immunotherapy technology are highlighted.In this paper,the latest research on the safety of cell therapy products at home and abroad is reviewed. |
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| Keywords: | Cell therapeutic products Adoptive cell transfer therapy ACT Quality control strategy Chimeric antigen receptor T-cell Immunotherapy CAR-T Gene modified T cell receptor TCR-T Viral vector |
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