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-001 titled "A Phase 2, Multicenter Study of the Efficacy and Safety of bb2121 in Subjects with Relapsed / Refractory Multiple Myeloma "

Proposed period of release:
01/12/2017 to 01/02/2020

Name of the Institute(s) or Company(ies)
Celgene Corporation, 86 Morris Avenue, Summit, New Jersey 07901;

3. Is the same GMO release planned elsewhere in the Community?
Belgium; Germany; France; Italy;

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

GMO characterization

GMO is a:
Other: mammal

Identity of the GMO:
Homo Sapiens

The GMO, referred to as bb2121, is defined as anti-BCMA CAR+ T cells, where human autologous T Cells are transduced with a recombinant lentivirus (Anti-BCMA02 CAR lentiviral vector).
Anti-BCMA02 CAR lentiviral vector: a recombinant HIV-1 RNA lentivirus manufactured with multiple plasmids designed to express all the packaging components to generate a modified recombinant lentiviral vector. Anti-BCMA02 CAR lentiviral vector packaged RNA transcript encodes for a chimeric antigen receptor (CAR) that recognizes the cell-surface marker B cell maturation antigen (BCMA).
Autologous T cells: 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:
02/03/2018 00:00:00