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Notification report


Full notification file


General information

Notification Number
B/SE/19/2019-001413-16

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
09/06/2020

Title of the Project
A Phase 3 Randomized Study Comparing JNJ-68284528, a Chimeric Antigen Receptor Tcell (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 Myeloma01082020

Proposed period of release:
01/08/2020 to 31/12/2045

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?
Yes:
Belgium; Germany; Denmark; Spain; France; United Kingdom; Italy; Netherlands; Sweden;

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

If yes, notification number(s):
B/ES/18/32; B/ES/19/16; B/ES/19/25;

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The GMO, refered to as JNJ-68284528consists 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
HumanHomoSapiens/--

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known