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Full notification Final report - General information Notification Number B/NL/22/006 Member State to which the notification was sent Netherlands Date of acknowledgement from the Member State Competent Authority 10/06/2022 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: 01/07/2022 to 28/02/2049 Name of the Institute(s) or Company(ies) University Medical Center Groningen, Hanzeplein 1, 9713GZ, the Netherlands
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany; Spain; Netherlands; Sweden;
Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: Other 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 HLAA*02 Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Human Genus: Species: Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Yes
07/04/2022
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