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Full notification Final report - General information Notification Number B/NL/22/008 Member State to which the notification was sent Netherlands Date of acknowledgement from the Member State Competent Authority 16/06/2022 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: 01/06/2022 to 28/02/2049 Name of the Institute(s) or Company(ies) University Medical Center Utrecht, University Medical Center Utrecht
Is the same GMO been notified elsewhere by the same notifier? No 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-B Receptor II (dnTGF-BRII) or CD8a. 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
07/06/2022
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