Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has garnered interest among researchers in the field of cell and gene therapy. Merging the benefits of CAR technology with Tregs offers a novel and promising therapeutic option for durable reshaping of undesired immune responses following solid organ or hematopoietic stem cell transplantation, as well as in immune-related disorders. However, major challenges remain for developing a standardized and robust good manufacturing practice (GMP)-compliant manufacturing process for CAR-Treg cells. We review current progress in the field and recommend ways to improve CAR-Treg manufacturing processes based on lessons learned from first-generation Treg therapeutics as well as from anticancer CAR-T cell development.

嵌合抗原受体（CAR）技术及其在调节性T细胞（Tregs）中的应用引起了细胞和基因治疗领域研究人员的兴趣。将CAR技术的优势与Tregs融合在一起，为持久地重塑实体器官或造血干细胞移植以及免疫相关疾病后的不良免疫反应提供了一种新颖而有前途的治疗选择。但是，为CAR-Tr​​eg电池开发标准化且鲁棒的符合良好生产规范（GMP）的制造工艺仍然面临主要挑战。我们将从第一代Treg治疗药物以及抗癌CAR-T细胞开发中汲取的经验教训总结一下该领域当前的进展，并提出改进CAR-Tr​​eg制造工艺的方法。