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Notification report


Full notification file


General information

Notification Number
B/ES/15/08

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
23/10/2015

Title of the Project
CTL019 Autologous genetically modified T cells, intravenous infusion
Treatment of relapsed/refractory B cell malignancies


Proposed period of release:
01/01/2016 to 31/12/2020

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; Netherlands; Norway;

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: Mammals

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:
Yes
14/12/2015 00:00:00
Remarks: