Full notification file
General informationNotification NumberB/NL/19/021Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority03/09/2019Title of the ProjectClinical Trials to Assess the Safety and/or Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells (GSK33777794), alone or in combination with other agents, in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 Participants with NY-ESO-1 and/or LAGE-1a Positive Cancers.Proposed period of release:31/08/2019 to 30/09/2049Name of the Institute(s) or Company(ies)GlaxoSmithKline R&D, ;
3. Is the same GMO release planned elsewhere in the Community?Yes: Germany; Spain; France; United Kingdom; Italy; Has the same GMO been notified elsewhere by the same notifier?YesIf yes, notification number(s): B/ES/17/07; B/ES/19/04; GMO characterizationGMO is a:Other: Identity of the GMO:The investigational product, also called GSK3377794, is comprised of autologous T cells that have been transduced with GSK3988862A, a self-inactivating lentiviral vector encoding a T cell receptor (TCR) targeted to recognize NY-ESO-1/LAGE1.Information relating to the recipient or parental organisms from wich the GMO is derivedCommon Name | Genus | Species | Subspecies | Strain | Pathovar | Human | Homo | Sapiens | - | - | - |
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European Commission administrative informationConsent given by the Member State Competent Authority:Not known