Aucatzyl: which tox species, and why?

“Per the applicant, conventional nonclinical toxicology studies were not conducted because they do not yield clinically relevant information for a CAR T cell product.”

“Aucatzyl, a patient-specific product, is not appropriate for administration to immunocompetent animals, as the T cells will not engraft.”

“Despite minor differences between the nonclinical and clinical products, the constructs assessed, including the binding domain, were identical and therefore the nonclinical product is considered appropriate to assess safety and activity in the nonclinical program.”