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
Trials to assess safety, tolerability and recommended phase 2 dose (RP2D) of NY-ESO-1 and LAGE-1a specific T cells, alone or in combination with other agents, in HLA-A*02+ participants with NY-ESO-1 and/or LAGE-1a positive advanced tumors

Proposed period of release:
01/09/2020 to 28/02/2049

Name of the Institute(s) or Company(ies)
Stichting Het Nederlands Kanker Instituut, Plesmanlaan 121
1066 CX Amsterdam
PO Box 90203
1006 BE Amsterdam;

3. Is the same GMO release planned elsewhere in the Community?
Germany; Netherlands; Sweden;

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The investigational products, also called GSK3845097 and GSK3901961 Dispersions for Infusion, comprises autologous T cells that have been transduced with either GSK4004397A or GSK4004416A Lentiviral Vector, a self-inactivating lentiviral vector to co-express an affinity-enhanced NY-ESO-1/LAGE-1a-specific T-cell receptor (TCR) and either the dominant negative TGF-β Receptor II (dnTGF-βRII) or CD8α. The TCR is able to recognise the shared tumoral antigen NY-ESO-1/LAGE-1a amino acid motif “SLLMWITQC” complexed with HLA-A*02.

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:
13/11/2020 00:00:00