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Notification report


Full notification file


General information

Notification Number
B/NL/19/002

Member State to which the notification was sent
Netherlands

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

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 31/12/2049

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


3. Is the same GMO release planned elsewhere in the Community?
Yes:
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?
No

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
02/07/2019 00:00:00
Remarks: