| 侯田田,黄瑛,霍艳.CAR-T细胞治疗产品非临床药效学研究关注点[J].中国药事,2018,32(9):1232-1238 |
| CAR-T细胞治疗产品非临床药效学研究关注点 |
| Considerations of Non-clinical Pharmacodynamic Study of CAR-T Cell Therapy Products |
| 投稿时间：2018-08-20 |
| DOI：10.16153/j.1002-7777.2018.09.013 |
| 中文关键词: CAR-T细胞 药效学研究 抗肿瘤活性 毒性 |
| 英文关键词: CAR-T cells pharmacodynamic study antitumor activity toxicity |
| 基金项目:十二五国家科技重大专项"生物大分子药物特殊评价关键技术研究"（编号2015ZX09501007-004）；中国食品药品检定研究院学科带头人培养基金（编号2015X1） |
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| 中文摘要: |
| CAR-T细胞（Chimeric Antigen Receptor T Cells，CAR-T）是一种表达嵌合抗原受体的基因工程T细胞，也称"活的药物"，可以增强基因工程T细胞的特异性，能够以MHC （主要组织相容性复合体，Major Histocompatibility Complex，MHC）非依赖性的方式高度靶向肿瘤抗原，是治疗肿瘤的一种新手段。最近，临床上使用CAR-T细胞治疗复发、难治性血液恶性肿瘤和多发性骨髓瘤取得了很好的疗效；同时，采用CAR-T细胞治疗实体瘤的研发也在积极开展。根据所构建的CAR-T细胞不同的适应证和作用原理，构建不同的动物肿瘤模型，研究CAR-T细胞在动物模型的抗肿瘤活性，可以对CAR-T细胞进行概念验证性研究并证明其体内药效学活性，为临床研究提供有力的数据支持。 |
| 英文摘要: |
| Chimeric antigen receptor T (CAR-T) cells are genetically engineered T cells that express chimeric antigen receptors, also known as "living drugs". CAR-T cells can enhance the specificity of genetically engineered T cell, highly target tumor antigens in a major histocompatibility complex (MHC)-independent manner and provide a new approach to the treatment of tumors. Recently, clinical use of CAR-T cells for the treatment of relapsed, refractory hematological malignancies and multiple myeloma has achieved good results; at the same time, CAR-T cells can also be used to treat solid tumors. According to the different indications and mechanism of action of CAR-T cells, different animal tumor models were constructed to study the anti-tumor activities of CAR-T cells in animal models. Proof-of-concept studies could be carried out and in vivo pharmacodynamic activity could be confirmed so as to provide supportive data for clinical study of CAR-T cells. |
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