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
Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)

Proposed period of release:
01/01/2020 to 15/12/2025

Name of the Institute(s) or Company(ies)
GlaxoSmithKline R&D, ;

3. Is the same GMO release planned elsewhere in the Community?
Spain; France; United Kingdom; Italy; Netherlands;

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

If yes, notification number(s):
B/ES/17/07; B/ES/19/04;

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The investigational product, also called GSK3377794, is comprised of autologous T cells that have been transduced with GSK3988862A, a self-inactivating lentiviral vector encoding a T cell receptor (TCR) targeted to recognize NY-ESO-1/LAGE1.

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:
30/04/2020 00:00:00