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Since the first Chimeric Antigen Receptor T Cell (CAR-T) therapeutic drug was approved in 2017, cellular immunotherapy drugs have continued to develop and become a hot spot in the field of biopharmaceuticals. In recent years, with the development of biotechnology, new CAR-T designs have emerged, and their indications have also expanded from hematological tumors to solid tumors, autoimmune diseases, and viral infections. Through optimized design, the activity of novel CAR-T cells has been continuously enhanced, while the toxicity reduced. Meanwhile, in order to further explore the safety and efficacy of CAR-T cells, its non-clinical evaluation models and methods have constantly been improving. In order to provide new ideas and considerations for the safety evaluation of immune cell therapy products, the latest research progress of CAR-T cell therapy and related new non-clinical evaluation methods are reviewed.

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自2017年全球首个嵌合抗原受体T细胞（chimeric antigen receptor T cell, CAR-T）治疗药物获批以来，细胞免疫治疗药物发展迅速，已成为生物制药领域的热点赛道之一。近年来，随着生物技术的发展，新型CAR-T设计不断涌现，其适应证也从血液肿瘤扩大到实体瘤、自身免疫病以及病毒感染等领域。通过优化设计，新型CAR-T细胞活性不断增强，而毒性有所降低。与此同时，为进一步探究CAR-T细胞的安全性与有效性，其非临床研究模型与方法也在不断改进。本文综述了近年来CAR-T细胞疗法的最新研究进展，并对相关非临床研究新方法进行了简要介绍，以期为免疫细胞治疗产品的安全性评价提供新的思路与考虑要点。

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张嘉慧，女，硕士研究生，研究方向：药物评价。E-mail: zhangjh228@mail2. sysu.edu.cn。

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张嘉慧，女，硕士研究生，研究方向：药物评价。E-mail: zhangjh228@mail2. sysu.edu.cn。

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