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
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?

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

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

European Commission administrative information

Consent given by the Member State Competent Authority:
13/12/2018 00:00:00