A guide to the collection of T-cells by apheresis for ATMP manufacturing-recommendations of the GoCART coalition apheresis working group

Autologous chimeric antigen receptor-modified T-cells (CAR-T) provide meaningful benefit for otherwise refractory malignancies. As clinical indications for CAR-T cells are expanding, hospitals hitherto not active in the field of immune effector cell therapy will need to build capacity and expertise. The GoCART Coalition seeks to disseminate knowledge and skills to facilitate the introduction of CAR-T cells and to standardize management and documentation of CAR-T cell recipients, in order to optimize outcomes and to be able to benchmark clinical results against other centers. Apheresis generates the starting material for CAR-T cell manufacturing. This guide provides some initial suggestions for patient's apheresis readiness and performance to collect starting material and should thus facilitate the implementation of a CAR-T-starting material apheresis facility. It cannot replace, of course, the extensive training needed to perform qualitative apheresis collections in compliance with national and international regulations and assess their cellular composition and biological safety.

Automated summary

Autologous CAR-T cells offer significant benefits for refractory malignancies. Hospitals not previously involved in immune effector cell therapy will need to develop capacity and expertise to integrate CAR-T cells. The GoCART Coalition aims to disseminate knowledge and skills, standardize management and documentation, and benchmark clinical results of CAR-T cell recipients. This guide provides initial suggestions for apheresis readiness and starting material collection, but comprehensive training is necessary for compliance with regulations and assessment of cellular composition and safety.