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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