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Notification report


Full notification file


General information

Notification Number
B/NL/20/003

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
06/04/2020

Title of the Project
Clinical studies with MB-CART2019.1, a product consisting of
ex-vivo lentiviral transduced T-cells using a replication-deficient
lentiviral vector.


Proposed period of release:
01/04/2020 to 31/12/2040

Name of the Institute(s) or Company(ies)
AMC Amsterdam, Meibergdreef 9
1105 AZ Amsterdam
A’dam
The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
No

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

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:
Yes
17/06/2020 00:00:00
Remarks: