赵真 李刚 徐瑛

    摘 要 免疫细胞疗法作为目前最先进的疗法之一，在癌症等疾病的治疗中起着重要作用。免疫细胞治疗药物由于在原料来源和制备工艺等方面与传统药物差异很大，临床试验阶段存在诸多不确定因素和风险。本文通过梳理国内外相关指导原则，结合我国临床试验实施现况，就免疫细胞治疗药物临床试验的风险管理作一探讨，供业界借鉴和参考。

    关键词 免疫细胞治疗药物 临床试验 风险管理

    中图分类号：R951 文献标志码：C 文章编号：1006-1533(2021)13-0010-04

    Risk management of clinical trials of immune cell therapy drugs

    ZHAO Zhen， LI Gang， XU Ying

    (Shanghai Center for Drug Evaluation and Inspection， Shanghai 201203， China)

    ABSTRACT As one of the most advanced therapies， immune cell therapy plays an important role in the treatment of cancer and other diseases. There are many uncertain factors and risks in the clinical trials of immune cell therapy drugs， which are due to their great differences from traditional medicinal products in terms of cell source and manufacturing process. We review the relevant guidelines， investigate the current situation of clinical trial implementation in China， and discuss the risk management of clinical trials of immunotherapy so as to provide reference for its clinical use.

    KEy WORDS immune cell therapy drugs； clinical trials； risk management ......