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Notification report


Full notification file


General information

Notification Number
B/ES/19/25

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
10/01/2019

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

Has the same GMO been notified elsewhere by the same notifier?
No

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known