Back

Notification report


Full notification file


General information

Notification Number
B/ES/21/10

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
18/02/2021

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?
Yes:
Austria; Belgium; Germany; Spain; France; United Kingdom; Italy; Netherlands; Sweden; Lithuania;

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known