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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。
Tumor immune cell therapy is an important means of tumor immunotherapy, which has shown a good prospect in clinical research. However, with the rapid development of tumor immune cell therapy, it should be noted that the unique characteristics of this therapy bring new difficulties and challenges to the design and evaluation of clinical trials. Immune-related response criteria (irRC) aims to better evaluate the efficacy of immunotherapy. In clinical trials, irRC is widely used as an evaluation criterion and has been used in clinical research in combination with the traditional WHO or RECIST evaluation system Tools, and further offers immunotherapy options for the end of clinical trials. Based on the dual attributes of drugs and technologies for immune cell therapy, this article summarizes the key points of the collection, screening, reagents and other materials used in the process of immune cells, as well as the quality control of process and finished products. In addition, Clinical trial unified technical specifications and test standards for discussion. I sincerely hope that China’s tumor immune cell therapy industry in the continuous innovation, come up with more convincing multicenter randomized controlled clinical evidence, thus promoting the vigorous development of China’s tumor immunotherapy.