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Notification report


Full notification file


General information

Notification Number
B/ES/16/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
08/09/2016

Title of the Project
Study of JCAR015 in clinical trials with patients with B cell malignancies

Proposed period of release:
01/12/2016 to 31/12/2020

Name of the Institute(s) or Company(ies)
Celgene Corporation, 86 Morris Avenue, Summit, New Jersey 07901;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Belgium; Germany; France; United Kingdom; Italy;

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

If yes, notification number(s):


GMO characterization

GMO is a:
Other: human

Identity of the GMO:
Autologous CD3+ T cells expressing a CD19-specific CAR comprised of an extracellular scFv
binding domain derived from a murine CD19-specific hybridoma cell line (SJ25C1), CD28
transmembrane and cytoplasmic domain, and CD3ΞΆ signaling domain.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
HumanSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/12/2016 00:00:00
Remarks: