Cabaletta Bio disclosed that the first two patients have been dosed with its investigational autologous CD19 CAR T therapy rese-cel (resecabtagene autoleucel) after automated manufacture on Cellares’ Cell Shuttle instrument. The company said the products met release criteria and were produced through Cellares’ automated manufacturing platform. Cabaletta framed the dosings as a demonstration of Cellares’ GMP manufacturing and supply-chain capabilities, aimed at enabling scalable production of autologous cell therapies. Cellares’ CEO also characterized the milestone as a step toward breaking the longstanding manufacturing model that has limited autologous CAR-T access. Rese-cel is engineered with a fully human CD19 binder and a 4-1BB co-stimulatory domain for autoimmune indications, designed to transiently and deeply deplete CD19-positive cells to reset immune responses without chronic therapy.
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