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Notification report


Full notification file


General information

Notification Number
B/ES/18/30

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
10/10/2018

Title of the Project
A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

Proposed period of release:
01/10/2018 to 31/01/2020

Name of the Institute(s) or Company(ies)
Celgene Corporation, ;


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

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

If yes, notification number(s):
B/ES/17/18;

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
The GMO, referred to as bb2121, is an autologous Homo Sapiens T lymphocyte population transduced with the anti-BCMA02 CAR lentiviral vector (LVV), which encodes a chimeric antigen receptor (CAR) targeting the human B cell maturation antigen (BCMA).

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
05/06/2019 00:00:00
Remarks: