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Notification report


Full notification file


General information

Notification Number
B/ES/17/04

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
19/01/2017

Title of the Project
Expanded treatment protocol for relapsed/refractory pediatric/young adult acute lymphoblastic leukemia patients to be treated with CTL019.

Proposed period of release:
01/03/2017 to 01/06/2020

Name of the Institute(s) or Company(ies)
Novartis Pharma AG, Postfach, 4002 Basel, Switzerland;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Belgium; Germany; Spain; France; Italy; Norway;

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

If yes, notification number(s):
B/DE/15/PEI/2484; B/ES/15/08; B/NL/15/012;

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
CD4+ and CD8+ T cells transduced with a replication-deficient HIV-1 derived viral vector
to express a transmembrane chimeric (murine/human) antigen receptor (CAR).


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