Chimeric antigen receptor (CAR) T cell products are human gene therapy products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes.
This draft FDA guidance is intended to assist sponsors, including industry and academic sponsors, developing CAR T cell products. In this guidance the FDA provide CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design.
Recommendations specific to autologous or allogeneic CAR T cell products are noted in this guidance. It also provides recommendations for analytical comparability studies for CAR T cell products. BioPhorum CGT Regulatory Strategy workstream members provide feedback on the draft.