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Notification report


Full notification file


General information

Notification Number
B/CZ/17/02

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority
16/11/2017

Title of the Project
Safety of CART19 cell manufactured by piggyBac mediated gene transfer for the therapy of lymphoid malignancies.

Proposed period of release:
01/01/2018 to 31/12/2020

Name of the Institute(s) or Company(ies)
Institute of Hematology and Blood Transfusion (IHBT), ;


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: human

Identity of the GMO:
Human in vitro expanded CD3+ T cells transduced with a piggyBac transposon vector carrying a Chimeric Antigenic Receptor (CAR) transgene. The CAR contains a scFv domain from an antibody recognizing human CD19 fused with hinge and transmembrane domains of human CD8 and with intracellular domains of the human genes 4-1BB and CD3-zeta.

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:
Not known