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Notification report


Full notification file


General information

Notification Number
B/DE/16/PEI2903

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
17/10/2016

Title of the Project
Single center, open label, phase I study of intracranial injection of NK-92/5.28.z cells in patients with recurrent HER2- positive glioblastoma (CAR2BRAIN)

Proposed period of release:
01/01/2017 to 30/11/2019

Name of the Institute(s) or Company(ies)
Goethe University Frankfurt / Main, University Hospital Frankfurt
Theodor-Stern-Kai 7
60596 Frankfurt / Main
Germany;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Genus: Human
Species: Homo Sapiens Sapiens
The GMO/IMP consists of human lymphocytes (natural killer cells) in form of NK-92 cells transduced ex vivo with the lentiviral vector PS-5.28.z-W (alternative designation: pHR´-SF-5.28.z) containing a synthetic codon- optimized gene FRP5hCD8CD28zeta encoding the ErbB2-specific chimeric antigen receptor 5.28.z for the treatment of HER2-positive brain tumors.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Lentiviral vectorsLentivirusHuman immunodeficiency virus (HIV)HIV-1--

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
01/06/2017 00:00:00
Remarks: