Full notification file
General informationNotification NumberB/DE/17/PEI2927Member State to which the notification was sentGermanyDate of acknowledgement from the Member State Competent Authority09/11/2016Title of the ProjectTesting the safety and efficacy of KTE-C19 in patients with refractory or relapsed B cell malignancies. KTE-C19 is a novel adoptive cellular immunotherapy for cancer whereby autologous T cells are genetically modified/transduced ex vivo by a replication-deficient retroviral vector to express anti-CD19 chimeric antigen receptors (CAR) on the surface of T cells to target malignant B cells expressing CD19 antigens.Proposed period of release:01/01/2016 to 31/12/2041Name of the Institute(s) or Company(ies) Universitätsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik I.;
Universitätsklinikum Essen, Klinik für Hämatologie;
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklink I;
3. Is the same GMO release planned elsewhere in the Community?Yes: Germany; France; Netherlands; Has the same GMO been notified elsewhere by the same notifier?YesIf yes, notification number(s): GMO characterizationGMO is a:Other: MammalIdentity of the GMO:Human T CellsInformation relating to the recipient or parental organisms from wich the GMO is derivedCommon Name | Genus | Species | Subspecies | Strain | Pathovar | Human | Homo | Sapiens | - | - | - |
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European Commission administrative informationConsent given by the Member State Competent Authority:Yes05/07/2017 00:00:00Remarks: