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Notification report


Full notification file


General information

Notification Number
B/ES/18/24

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
29/08/2018

Title of the Project
Phase 1, open label, non-comparative, study to evaluate the safety and the ability of UCART19 to induce molecular remission in paediatric patients with relapsed / refractory B cell acute lymphoblastic leukaemia (R/R B-ALL).

Proposed period of release:
01/12/2018 to 30/04/2020

Name of the Institute(s) or Company(ies)
Carmen Gorostiaga Ayesteran, ;


3. Is the same GMO release planned elsewhere in the Community?
No

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Genus: Homo,
Species: sapiens,
Common name: human
Human genetically modified allogeneic T Lymphocytes, transduced with replication-deficient/self-inactivating lentiviral vector to express CD19CAR/RQR8 and transiently modified with (Transcription activator like effector nucleases) TALEN 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:
Not known