Back

Notification report


Full notification file


General information

Notification Number
B/SE/20/003908-14

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
05/02/2021

Title of the Project
Multicenter Phase II trial of MB-CART2019.1 for the Treatment of Patients with relapsed/refractory DLBCL

Proposed period of release:
01/01/2021 to 30/06/2022

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; Germany; Spain; France; Italy; Netherlands; Sweden; Lithuania;

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

GMO characterization

GMO is a:
Other: mammals

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