隨著醫(yī)學技術(shù)的不斷進步和科學研究的不斷深入，腫瘤免疫細胞治療作為一種新的治療方式受到社會各界的廣泛關(guān)注，成為輔助腫瘤治療的一種新手段。過繼免疫細胞治療相繼出現(xiàn)了不同類型的細胞——T淋巴細胞、細胞因子誘導的殺傷（CIK）細胞、樹突狀細胞（DC）-CIK細胞、自然殺傷（NK）細胞和腫瘤浸潤性淋巴細胞（TIL）細胞等。日前開展的多種類型的免疫細胞臨床研究在腫瘤治療中已經(jīng)體現(xiàn)出顯著的療效，腫瘤免疫治療成為快速發(fā)展的研究領(lǐng)域。如何選擇腫瘤免疫細胞治療方法和時機，治療過程中的質(zhì)量控制和質(zhì)量管理應(yīng)當怎么做，如何得到更有說服力的循證醫(yī)學證據(jù)，是值得深入探索的重要問題。對目前的腫瘤免疫細胞治療現(xiàn)狀和未來5年發(fā)展做一概述，初步探討臨床研究中的質(zhì)量控制和質(zhì)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

國家科技重大專項課題——重大新藥創(chuàng)制（2016ZX09101094）；北京市科委企業(yè)技術(shù)創(chuàng)新平臺建設(shè)（Z181100000518028）