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Notification report

Full notification file


General information

Notification Number
B/NL/17/006

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
29/11/2017

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

Proposed period of release:
01/11/2017 to 31/12/2047

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?
No

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

If yes, notification number(s):
B/DE/15/PEI/2484; B/DE/15/PEI2482; B/ES/15/08; B/ES/17/04;

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 Name	Genus	Species	Subspecies	Strain	Pathovar
Human	Homo	Sapiens	-	-	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known