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 testing of JNJ-68284528, composed of autologous T cells genetically modified with a lentiviral vector (LVV) to express a chimeric antigen receptor (CAR) that, upon reinfusion into the patient, recognize and kill B-cell maturation antigen (BCMA)-expressing tumor cells.

Proposed period of release:
01/08/2019 to 01/12/2049

Name of the Institute(s) or Company(ies)
Janssen-Cilag International NV, Turnhoutseweg 30
Stichting VU medisch centrum, Amsterdam;

3. Is the same GMO release planned elsewhere in the Community?
Austria; Belgium; Germany; Denmark; Spain; France; United Kingdom; Greece; Italy; Netherlands; Sweden; Czech Republic;

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The GMO, refered to as JNJ-68284528 consists of autologous T cells genetically modified to express a synthetic chimeric antigen receptor (CAR). The CAR recognises the cell surface marker 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