Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

Title of the Project
A global randomized multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM).

Proposed period of release:
01/09/2019 to 30/11/2021

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?
Belgium; Denmark; Spain; France; United Kingdom; Italy; Netherlands; Sweden;

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

If yes, notification number(s):

GMO characterization

GMO is a:
Other: mammal

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 signalling domains.

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

European Commission administrative information

Consent given by the Member State Competent Authority:
26/06/2018 00:00:00