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Notification report


Full notification file


General information

Notification Number
B/SE/19/004446-14-2

Member State to which the notification was sent
Sweden

Date of acknowledgement from the Member State Competent Authority
15/06/2020

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:
15/01/2021 to 18/10/2022

Name of the Institute(s) or Company(ies)
GlaxoSmithKline AB, ;


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

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

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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known