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
Clinical trials testing bb2121, consisting of autologous T lymphocytes ex-vivo transduced bya replication-defective lentiviral vector to express anti-BCMA chimeric antigen receptors(CAR) to target tumor cells expressing the human B cell maturation antigen (BCMA), inpatients with multiple myeloma

Proposed period of release:
01/10/2019 to 31/12/2040

Name of the Institute(s) or Company(ies)
Stichting VU medisch centrum, Amsterdam;

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: mammals

Identity of the GMO:
The GMO, referred to as bb2121, is an autologous Homo sapiens T lymphocyte populationtransduced with the anti-BCMA02 CAR lentiviral vector (LVV), which encodes a chimericantigen 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

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known