FDA published final guidance on Jan. 30, 2024 that provides consideration for the development of chimeric antigen receptor (CAR) T-cell products. According to FDA, “[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.”
The guidance provides sponsors with information to help develop CAR T-cell products including specific recommendations regarding chemistry, manufacturing, and controls (CMC), pharmacology and toxicology, and clinical study design. Considerations for autologous or allogeneic CAR T-cell products are addressed as well as analytical comparability studies.
