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Notification report


Full notification file


General information

Notification Number
B/NL/19/015

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
17/07/2019

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?
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: 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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known