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Notification report


Full notification file


General information

Notification Number
B/ES/19/18

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
09/10/2019

Title of the Project
A phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or resistant B-NHL

Proposed period of release:
01/03/2019 to 31/12/2022

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:
Austria; Belgium; France; Italy; Netherlands; Lithuania;

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
T cells transduced with a replication-deficient lentiviral vector harbouring the chimeric antigen receptor for targeting CD20 and 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