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 study 68284528MMY2001: A Phase 1b/2, Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects With Relapsed or Refractory Multiple Myeloma.

Proposed period of release:
01/03/2019 to 01/12/2049

Name of the Institute(s) or Company(ies)
Erasmus MC, Erasmus MC
s-Gravendijkwal 230
Afdeling Urologie
Rotterdam 3015 CE
The Netherlands;

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