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General information Notification NumberB/DE/21/PEI4218Member State to which the notification was sentGermanyDate of acknowledgement from the Member State Competent Authority26/08/2020Title of the ProjectTIGER-CTL019 - Phase II trial of TisaGenlecleucel in Elderly Patients with First-Relapsed or Primary Refractory Agressive B-cell Non-Hodgkin LymphomaProposed period of release:01/10/2020 to 31/12/2023Name of the Institute(s) or Company(ies) Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik I. Is the same GMO been notified elsewhere by the same notifier? NoHas the same GMO been notified elsewhere by the same notifier?No
GMO characterization GMO is a: OtherIdentity of the GMO: Autologous T cells transduced with a replication-deficient HIV-1 derived viral vector toexpress a chi- meric (murine/human) antigen receptor (CAR)Information relating to the recipient or parental organisms from which the GMO is derived Common Name: HumanGenus: Homo Species: Homo SapiensSubspecies: Strain: Pathovar:
European Commission administrative Information Consent given by the Member State Competent Authority: Not known