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Full notification
Final report
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General information Notification NumberB/NL/21/015Member State to which the notification was sentNetherlandsDate of acknowledgement from the Member State Competent Authority17/06/2021Title of the ProjectClinical testing of TX200-TR101, an autologous antigen-specific chimeric antigenreceptor (CAR) T regulatory cell therapy.Proposed period of release:01/03/2020 to 31/12/2041Name of the Institute(s) or Company(ies)Sangamo Therapeutics France SAS Is the same GMO been notified elsewhere by the same notifier? Yes: Belgium; Germany; France; United Kingdom; Has the same GMO been notified elsewhere by the same notifier?YesIf yes, notification number(s):
GMO characterization GMO is a: OtherIdentity of the GMO: The GMO / IMP consists of human regulatory T cells transduced ex vivo with areplication-deficient self-inactivating lentiviral vector carrying a genetic elementencoding the expression of a Chimeric Antigen Receptor (CAR).Information relating to the recipient or parental organisms from which the GMO is derived Common Name: HumanGenus: Human Species: Homo SapiensSubspecies: Strain: Pathovar:
European Commission administrative Information Consent given by the Member State Competent Authority: Yes 06/07/2021