Toward an Optimized Process for Clinical Manufacturing of CAR-Treg Cell Therapy

Chimeric antigen receptor (CAR) technology and its application to regulatory T cells (Tregs) has been hailed as the next scientific breakthrough 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, robust, and reliable good manufacturing practice (GMP)-compliant manufacturing process for CAR-Treg cells. We review current progress in the field and recommend ways to improve current CAR-Treg manufacturing processes based on lessons learned from first-generation Treg therapeutics as well as from anticancer CAR-T cell development.