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 Recommended Phase 2 Dose of Next Generations of Autologous Enhanced NY-ESO-1/ LAGE-1a TCR Engineered T-cells, alone or in combination with other agents, in Participants with Advanced Tumors

Proposed period of release:
15/12/2020 to 28/02/2023

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

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

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

GMO characterization

GMO is a:
Other: mammals

Identity of the GMO:
The investigational product, also called GSK3901961 Dispersion for Infusion, comprises autologous T cells that have been transduced with 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 CD8. 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:
Not known