Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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

3. Is the same GMO release planned elsewhere in the Community?

Has the same GMO been notified elsewhere by the same notifier?

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:
01/06/2017 00:00:00