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Notification report


Full notification file


General information

Notification Number
B/NL/20/012

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
20/07/2020

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?
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 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
HumanHomoSapiens---

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
13/11/2020 00:00:00
Remarks: