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
Study bb2121-MM-002 A Phase 2, Multicohort, Open-label, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma Havin Progressed Within One Year of Initial Treatment (KarMMa-2)

Proposed period of release:
12/10/2018 to 01/01/2020

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

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

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

If yes, notification number(s):

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).
• Anti-BCMA02 CAR LVV is a replication defective, self-inactivating (SIN), recombinant human immunodeficiency virus type 1 (HIV 1) based LVV, encoding a CAR specific for BCMA.
• Autologous T cells are obtained by apheresis from patients diagnosed with BCMA-expressing multiple myeloma.

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:
30/01/2019 00:00:00