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Notification report


Full notification file


General information

Notification Number
B/DE/17/PEI3269

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
01/12/2017

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?
Yes:
Belgium; Spain; France; Italy;

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:
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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
22/05/2018 00:00:00
Remarks: