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Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products Draft Guidance for Industry was launched by FDA on March 21, 2022. It provides CAR-T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, clinical study design, and other important aspects. To provide references for sponsors, this article mainly introduces the clinical considerations for early-phase development of CAR-T cells for patients with cancer (hematologic malignancies and solid tumors), including study population, treatment plan, clinical pharmacology considerations, safety evaluation and monitoring, CAR-T cell persistence and long term follow-up, and allogeneic CAR-T cells. This article also introduces the information of chimeric antigen receptor T cell products in China, and discusses the similarities and differences of the clinical review of such products by regulatory agencies between China and the United States.

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美国FDA于2022年3月21日发布了“嵌合抗原受体T细胞产品研发考虑指南（草案）”，该指导原则包括嵌合抗原受体T细胞的药学、非临床研究、临床研究等研发考虑。本文主要介绍该指导原则中关于嵌合抗原受体T细胞治疗血液肿瘤和实体肿瘤的早期临床研发相关内容，包括受试人群、治疗计划、临床药理学考虑、安全性评估和检测、嵌合抗原受体T细胞的持续性和长期随访、异体嵌合抗原受体T细胞等方面。同时介绍了我国嵌合抗原受体T细胞产品的审评基本情况，比较我国和美国监管机构对该类产品临床审评考虑。

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赵晨阳，女，博士，助理研究员，主要从事细胞和基因治疗产品临床审评和监管科学研究。联系电话：(010)85243052，E-mail: zhaochy@cde.org.cn。

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赵晨阳，女，博士，助理研究员，主要从事细胞和基因治疗产品临床审评和监管科学研究。联系电话：(010)85243052，E-mail: zhaochy@cde.org.cn。

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