Rare manufacturing glitch raises concern over CAR-T therapies: study [Reuters]
bluebird bio, Inc. (BLUE)
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Source: Reuters
Rare manufacturing glitch raises concern over CAR-T therapies: study | Reuters 4 Min Read CHICAGO (Reuters) - A single leukemia cell inadvertently got mixed in with a batch of a patient’s immune cells that were being manufactured into a CAR-T cell therapy and it acquired resistance to the treatment with deadly results, University of Pennsylvania researchers reported on Monday. The mishap occurred in a 20-year-old leukemia patient treated with cells manufactured at the university, eventually causing a fatal relapse of the blood cancer, researchers reported in the journal Nature Medicine. The patient was entered in an early-stage trial of CTL019, a treatment eventually licensed to Novartis and sold under the brand name Kymriah, which became the first such gene therapy to win U.S. approval in 2017. Dr. Marco Ruella of the Center for Cellular Immunotherapies at the University of Pennsylvania, who led the study, said the case was “exceptionally rare,” noting that it is the only one out of
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