通用型CAR-T细胞药物的开发策略及临床研究进展

Development strategy and clinical research progress of universal chimeric antigen receptor T-cell drugs

嵌合抗原受体T细胞(chimeric antigen receptor T-cell,CAR-T)免疫疗法已在多种血液肿瘤的临床治疗中取得了突破性进展。然而,目前国内外获批上市的CAR-T细胞产品均属于自体CAR-T。相比于自体CAR-T治疗,通用型CAR-T优势显著,可满足更多患者的治疗需求,但同时也具有较高的技术壁垒。本文围绕通用型CAR-T进行综述,明确指出通用型CAR-T发展面临的两大挑战,并从引起两大难题的机制出发总结分析可行的解决策略,同时对国内外通用型CAR-T布局企业及其优势产品的最新临床进展进行综述,从另一方面探讨开发策略的可行性,以期为开发新一代通用型CAR-T细胞治疗产品提供思路。

Chimeric antigen receptor T-cell(CAR-T)immunotherapy has made a breakthrough in the clinical treatment of a variety of hematological tumors.However,the CAR-T cell products listed at China and abroad are all autologous CAR-T.Compared with autologous CAR-T treatment,universal CAR-T exhibits significant advantages,which could fulfill the treatment demand of more patients,but also displays high technical barriers.This paper reviews the universal CAR-T,clearly points out the two major challenges faced by the development of universal CAR-T,and then summarizes and analyzes the feasible solutions according to the mechanism causing the two major problems.This paper also summarizes domestic and foreign companies producing universal CAR-T and the latest clinical progress of their superior products,and then discusses the feasibility of the development strategy from another aspect,in order to provide ideas for developing a new generation of universal CAR-T cell therapy products.