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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI2927

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
09/11/2016

Title of the Project
Testing 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 31/12/2041

Name 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?
Yes

If yes, notification number(s):


GMO characterization

GMO is a:
Other: Mammal

Identity of the GMO:
Human T Cells

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
05/07/2017 00:00:00
Remarks: