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Notification report


Full notification file


General information

Notification Number
B/DE/19/PEI3518

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
10/08/2019

Title of the Project
CTL019 - Autologous genetically modified T cells, intravenous infusion. Treatment of relapsed/refractory B cell malignancies [FSa3] cell

Proposed period of release:
10/12/2018 to 30/08/2022

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:


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/ES/17/04; B/NL/15/012;

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
Autologous T cells transduced with a replication-deficient HIV-1 derived viral vector to express a chi- meric (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
14/03/2019 00:00:00
Remarks: