随着医学技术的不断进步和科学研究的不断深入，肿瘤免疫细胞治疗作为一种新的治疗方式受到社会各界的广泛关注，成为辅助肿瘤治疗的一种新手段。过继免疫细胞治疗相继出现了不同类型的细胞——T淋巴细胞、细胞因子诱导的杀伤（CIK）细胞、树突状细胞（DC）-CIK细胞、自然杀伤（NK）细胞和肿瘤浸润性淋巴细胞（TIL）细胞等。日前开展的多种类型的免疫细胞临床研究在肿瘤治疗中已经体现出显著的疗效，肿瘤免疫治疗成为快速发展的研究领域。如何选择肿瘤免疫细胞治疗方法和时机，治疗过程中的质量控制和质量管理应当怎么做，如何得到更有说服力的循证医学证据，是值得深入探索的重要问题。对目前的肿瘤免疫细胞治疗现状和未来5年发展做一概述，初步探讨临床研究中的质量控制和质量管理方向。

In recent years, with the continuous progress of medical technology and the deepening of scientific research, tumor immune cell therapy, as a new treatment method, has attracted wide attention and become an important method of adjuvant tumor therapy. In particular, different types of cells have emerged in adoptive immune cell therapy, such as T lymphocytes, CIK cells, DC-CIK cells, NK cells and TIL cells. Recently, clinical studies on immune cells have shown remarkable efficacy in clinic, thus tumor immunotherapy tend to be a rapidly developing field. How to select the method and timing for tumor immunotherapy, how to perform the quality control and quality management in the treatment process, and how to obtain more convincing evidences as evidence-based medicine are all important issues worthy of further exploration. In this paper, the current status of tumor immune cell therapy and its development in the next five years is summarized, the quality control and quality management content in clinical research are preliminarily discussed.

R926

国家科技重大专项课题——重大新药创制（2016ZX09101094）；北京市科委企业技术创新平台建设（Z181100000518028）