Journal article
Tisagenlecleucel cellular kinetics, dose, and immunogenicity in relation to clinical factors in relapsed/refractory DLBCL
R Awasthi, L Pacaud, E Waldron, CS Tam, U Jäger, P Borchmann, S Jaglowski, SR Foley, K Van Besien, ND Wagner-Johnston, MJ Kersten, SJ Schuster, G Salles, RT Maziarz, Ö Anak, C Del Corral, J Chu, I Gershgorin, I Pruteanu-Malinici, A Chakraborty Show all
Blood Advances | Published : 2020
Open access
Abstract
The anti-CD19 chimeric antigen receptor (CAR)-T cell therapy tisagenlecleucel was evaluated in the global, phase 2 JULIET study in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). We correlated tisagenlecleucel cellular kinetics with clinical/product parameters in 111 patients treated in JULIET. Tisagenlecleucel persistence in responders and nonresponders, respectively, was demonstrated for 554 and 400 days maximum by flow cytometry and for 693 and 374 days maximum by quantitative polymerase chain reaction (qPCR). No relationships were identified between cellular kinetics (qPCR) and product characteristics, intrinsic/extrinsic factors, dose, or immunogenicity. M..
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Funding Acknowledgements
This study and writing assistance were supported by Novartis Pharmaceuticals Corporation, East Hanover, NJ. Medical writing assistance was provided by Beena John and Rozena Varghese, CMPP, of C4 MedSolutions, LLC (Yardley, PA), a CHC Group company.