Risk Factors for CD19-Targeting CAR T Manufacturing Failure and Patient Outcomes: A Report from the UK National CAR T Panel

Vaishali Dulobdas,Amy A. Kirkwood,Fabio Serpenti, Brijesh Gautama, Aikaterini Panapoulou,Sumantha Gabriel,Ram Malladi, Jessica Pealing,Denise Bonney,Emma Nicholson,Caroline Besley, Sara Ghorashian,Elizabeth Davies, Jackie Chappell, Anne Black,Tobias Menne,Maeve O'Reilly,Robin Sanderson,Sridhar Chaganti

Blood（2023）

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摘要

CAR T manufacturing failure (MF) rates reported in literature range between 1-13%. In some cases the manufacturing process fails to yield a product and in others results in one which does not meet pre-specified criteria for release and labelled an out of specification (OOS) product. We conducted a multicentre retrospective review of factors contributing to MF and its impact on patient outcomes.

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