Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A Phase II randomised multicentre open label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed/refractory diffuse large B cell lymphoma (R R DLBCL), who are not eligible for high dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT)

Proposed period of release:
01/04/2021 to 30/06/2022

Name of the Institute(s) or Company(ies)
Miltenyi Biomedicine GmbH, Friedrich-Ebert-Stra├če 68, 51429 Bergisch Gladbach, Germany;

3. Is the same GMO release planned elsewhere in the Community?
Austria; Belgium; Germany; Spain; France; United Kingdom; Italy; Netherlands; Sweden; Lithuania;

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

If yes, notification number(s):

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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known