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.

Enrico Fritsche, Hans-Dieter Volk, Petra Reinke and Mohamed Abou-El-Enein of BCRT Charité Berlin 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.