[关键词]
[摘要]
免疫细胞治疗通过修复患者机体免疫系统、激发免疫功能成为肿瘤的一种新的治疗方法,已经被证实具有较好的安全性,在部分肿瘤患者中取得了良好的治疗效果。本文聚焦近年来国内外开展的CAR-T细胞、TCR-T 细胞、NK细胞、TIL 等免疫细胞治疗方法在肿瘤中的临床安全性和有效性,同时从技术、产业化、政策等三个层面,提出中国免疫细胞治疗领域存在的关键问题、挑战及相应的解决策略,包括原创性基础理论研究的加强,新技术的应用和转化,细胞产品制备及临床研究的规范,先进的自动化、工业化细胞生产工艺体系的完善,细胞治疗产业上游产品保障,创新能力强的高水平科研、临床研究队伍的培养和壮大,以及与细胞治疗技术发展相适应的政策法规、科学监管体系的建立和完善等。这些问题的解决,可确保中国免疫细胞治疗的良性发展。
[Key word]
[Abstract]
Immune cell therapy has become a new therapeutic method for tumors by repairing the immune system and stimulating the immune function of patients, and it has been proved to have good safety and favorable therapeutic effects in some tumor patients. This paper focuses on the clinical safety and effectiveness of immune cell therapies including CAR-T cells, TCR-T cells, NK cells and TIL,etc. in tumor treatment at home and abroad in recent years. At the same time, from three aspects of technology, industrialization and policy, we put forward the key problems, challenges and corresponding solutions in the field of immune cell therapy in China, including the strengthening of original basic theoretical research, the application and transformation of new technologies, the standardization of cell product preparation and clinical research, the improvement of automated and industrialized cell production process systems, the guarantee of upstream products in the cell therapy industry, the cultivation and expansion of high-level scientific research and clinical research teams with strong innovation ability, and the establishment and improvement of policies, regulations and scientific supervision system that are compatible with the development of cell therapy technology. Solving of these problems can ensure the benign development of immune cell therapy in China.
[中图分类号]
[基金项目]
国家自然科学基金(No. 82070617);国家重点研发计划(No. 2022YFC2304402)