Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent
Czech Republic

Date of acknowledgement from the Member State Competent Authority

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?

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

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known