[ 摘 要 ] 目前，越来越多的基因工程 T 细胞临床研究在中国开展，但尚无适用于临床研究中供医生参考的指导意见。中国 医药质量管理协会细胞治疗质量控制与研究专业委员会针对基因工程 T 细胞临床研究的特点，从开展临床研究医生的角度，对 患者的选择、细胞的采集与制备、细胞的储存与运输、围细胞输注期治疗及疗效评价等多方面，组织细胞治疗领域的多名专家， 综合国内外研究最新进展并结合临床实践经验，经多次讨论和修改，最终形成《基因工程 T 细胞临床研究专家指导意见（2021）》 （以下简称《本指导意见》）。本指导意见旨在为本领域的临床研究医生提供专业指导，保护临床研究中患者的安全并争取最大的获益。

[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.

国 家 重 点 研 发 计 划 重 点 专 项 资 助 项 目 （ No.2018YFC1313400） ； 重 大 新 药 创 制 科 技 重 大 专 项 资 助 项 目（ No.2020ZX09201-009）