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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI3205

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
29/09/2017

Title of the Project
Multicenter Phase I/II trial of MB-CART19.1 for the Treatment of Patients with CD19 positive ALL and B-NHL

Proposed period of release:
01/01/2018 to 30/09/2021

Name of the Institute(s) or Company(ies)
Miltenyi Biotec GmbH, Friedrich-Ebert-Stra├če 68, Bergisch Gladbach, Germany;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Other: human

Identity of the GMO:
T cells transduced with a replication-deficient lentiviral vector harbouring the chimeric antigen receptor for targeting CD19.

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