Intent-to-treat leukemia remission by CD19 CAR T cells of defined formulation and dose in children and young adults
Rebecca Gardner(Seattle Children's Hospital), Olivia Finney(Seattle Children's Hospital), Colleen Annesley(Seattle Children's Hospital), Hannah Brakke(Seattle Children's Hospital), Corinne Summers(Seattle Children's Hospital), Kasey J. Leger(Seattle Children's Hospital), Marie Bleakley(University of Washington), Christopher Brown(Seattle Children's Hospital), Stephanie Mgebroff(Seattle Children's Hospital), Karen S. Kelly‐Spratt(Seattle Children's Hospital), Virginia J. Hoglund(Seattle Children's Hospital), Catherine Lindgren(Seattle Children's Hospital), Assaf P. Oron(Seattle Children's Hospital), D. Li, Stanley R. Riddell(University of Washington), Julie R. Park(Seattle Children's Hospital), Michael C. Jensen(Seattle Children's Hospital)
Cited by 1,130Open Access
Abstract
remission rate was 93% in patients who received a CAR T-cell product and 100% in the subset of patients who received fludarabine and cyclophosphamide lymphodepletion. Twenty-three percent of patients developed reversible severe cytokine release syndrome and/or reversible severe neurotoxicity. These data demonstrate that manufacturing a defined-composition CD19 CAR T cell identifies an optimal cell dose with highly potent antitumor activity and a tolerable adverse effect profile in a cohort of patients with an otherwise poor prognosis. This trial was registered at www.clinicaltrials.gov as #NCT02028455.
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