Conference Proceedings
Clinical pharmacology of tisagenlecleucel (CTL019) in patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL)
Rakesh Awasthi, Constantine S Tam, Ulrich Jaeger, Samantha Jaglowski, Stephen Ronan Foley, Koen van Besien, Nina D Wagner-Johnston, Maria Jose Kersten, Stephen J Schuster, Gilles Salles, Richard T Maziarz, Ozlem Anak, Lida Bubuteishvili Pacaud, Lucien Gazi, Edward Waldron, Jason Hamilton, Iulian Pruteanu, Feng Tai, Karen Thudium Mueller, Edmund K Waller
CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2018
Abstract
Abstract Background: Tisagenlecleucel is a cellular immunotherapy that uses genetically modified autologous T cells to target CD19+ B cells. Little is known about the effects of dose and cellular kinetics on response and safety of tisagenlecleucel in r/r DLBCL patients (pts). Methods: Data from a pivotal phase 2 study (JULIET; NCT02445248) were used to characterize exposure, dose, response, and safety in r/r DLBCL pts. Results: Cellular kinetic parameters were summarized for 81 pts using qPCR measurements from peripheral blood only. The geo-mean AUC0-28d, Cmax, and median Tmax were similar in responding and nonresponding pts, suggesting similar ex..
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