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 68284528MMY3002: A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA, versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Subjects with Relapsed and Lenalidomide Refractory Multiple Myeloma.

Proposed period of release:
01/02/2020 to 31/10/2021

Name of the Institute(s) or Company(ies)
Janssen-Cilag International NV, Turnhoutseweg 30, Beerse, B-2340, Belgium;

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

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

GMO characterization

GMO is a:
Other: Mammal

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