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Notification report


Full notification file


General information

Notification Number
B/NL/19/018

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
04/09/2019

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?
Yes:
Austria; Belgium; Germany; Spain; France; United Kingdom; Italy; Sweden; Poland;

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

If yes, notification number(s):
B/ES/18/24;

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
20/01/2020 00:00:00
Remarks: