Back

Notification report


Full notification file


General information

Notification Number
B/ES/18/26

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/09/2018

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, 86 Morris Avenue, Summit, New Jersey 07901;


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).
• 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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known