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Full notification Final report - General information Notification Number B/PT/23/02 Member State to which the notification was sent Portugal Date of acknowledgement from the Member State Competent Authority 06/03/2023 Title of the Project An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-23) Proposed period of release: 01/09/2023 to 31/03/2031 Name of the Institute(s) or Company(ies) PPD Gobal Ltd, Sucursal em Portugal Avenida da Liberdade, 180-A, 4º Dto. 1250-146 Lisboa Portugal
Is the same GMO been notified elsewhere by the same notifier? Yes:
Austria; Denmark; Estonia; France; Italy; Netherlands; Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/DE/17/PEI2927; B/DE/17/PEI3320; 10953953; 9159321; B/SE/18/2017-002261-22; B/SE/2015-005010-30; GMO characterization GMO is a: Other Identity of the GMO: KTE-C19 (axicabtagene ciloleucel) comprises of autologous human T cells transduced with a replication-incompetent retroviral vector encoding an anti-CD19 chimeric antigen receptor. Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: Homo Species: Homo Sapiens Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known