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Notification report


Full notification file


General information

Notification Number
B/SE/19/2019-004081-18

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
11/03/2020

Title of the Project
A Phase 2, Open-label, Single-arm, Multicohort, Multicenter Trail to Evaluate Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)Proposed period of release.

Proposed period of release:
01/06/2020 to 01/01/2024

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:
Austria; Germany; Spain; France; United Kingdom; Italy;

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
JCAR017 is a second generation CAR T cell construct comprised of autologous CD4+ and CD8+ T cells expressing a CD19-specific CAR consisting of an scFv binding domain derived from the FMC63 murine CD19-specific mAb fused to the 4-1BB and CD3ΞΆ chain signaling domains.

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