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Full notification Final report - General information Notification Number B/DE/22/PEI4670 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 30/09/2021 Title of the Project A Multicentre, Open-Label, Single Ascending Dose, Dose Ranging, Phase I/IIa Studyto Evaluate the Safety and Tolerability of an Autologous Antigen-Specific ChimericAntigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor RenalTransplant Recipients Proposed period of release: 15/03/2022 to 04/03/2026 Name of the Institute(s) or Company(ies) Sangamo Therapeutics France SAS
Is the same GMO been notified elsewhere by the same notifier? Yes:
Belgium; France; Netherlands; Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/NL/20/001; GMO characterization GMO is a: Other Identity 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: Human Genus: Homo Species: Homo Sapiens Subspecies: Strain: Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known