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
UCART19, human genetically modified allogeneic T Lymphocytes for the treatment of relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia

Proposed period of release:
02/02/2020 to 31/03/2040

Name of the Institute(s) or Company(ies)
Princess Maxima Center for Pediatric Oncology, ;

3. Is the same GMO release planned elsewhere in the Community?
Austria; Belgium; Germany; Spain; France; United Kingdom; Italy; Sweden; Poland;

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

If yes, notification number(s):

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
Genus : Homo,
Species : sapiens,
Common name : human
Human genetically modified allogeneic T Lymphocytes, transduced with replicationdeficient/
self-inactivating lentiviral vector to express CD19CAR/RQR8 and transiently
modified with (Transcription activator like effector nucleases) TALENĀ® to inactivate
TRAC/CD52 genes.

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