肿瘤免疫细胞治疗是肿瘤免疫治疗的重要手段，在临床研究中显示出良好的应用前景。但在肿瘤免疫细胞治疗快速发展的同时，应该看到该疗法独有的特点对临床试验的设计和评价带来了新的困难与挑战。免疫相关反应标准（immune-related response criteria，irRC）旨在更好地评价免疫疗法的疗效，在临床试验中irRC作为评价标准被广泛使用，配合传统的WHO或RECIST评价体系，成为临床研究的有力工具，并进一步为免疫治疗提供了更多的临床试验终点的选择。基于免疫细胞治疗的药物和技术的双重属性，本文对免疫细胞采集、筛选、处理过程中所使用的试剂及其他材料，以及工艺、成品质控等多个环节的要点进行总结，并对多中心临床试验统一技术规范和检定标准进行探讨。笔者衷心希望我国肿瘤免疫细胞治疗行业在不断创新的同时，拿出更多令人信服的多中心随机对照的临床证据，从而推动我国肿瘤免疫治疗蓬勃发展。

Cellular immunotherapy of cancer is an important approach of cancer immunotherapy which showed a bright prospect for practical application in clinical research. However, with the rapid development of cellular immunotherapy of cancer, it should be aware that the unique characteristics of the therapy have also brought new challenges and difficulties to the design and evaluation of clinical trials. Immune related response criteria (irRC) has been designed to better evaluate curative efficacy of the immunotherapies. In clinical trials, irRC as evaluation standards was widely used, and became a powerful tool in clinical research coordinating with traditional WHO or RECIST evaluation system. And it further offer more choices of clinical trial endpoints for the immunotherapy. In this review, based on the dual attributes of drug and technique for cellular immunotherapy, reagents and other materials used in collection, screen and process of immunocytes as well as key points of technics and product quality control and other aspects were summed up. Uniform technical specification and testing standardsused in multi-centers of clinical trials were also explored. It was sincerely hoped that more convincing evidences of multi-center randomized controlled clinical trials could be provided by workers of cancer celluar immunotherapy in China with continuous innovation, of the celluar immunotherapy, so then to promote vigorous development of the cellular immunotherapy in China.

国家科技支撑计划（No.2015BAI12B12)；国家自然科学基金青年项目资助（No. 81401888）