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Full notification Final report - General information Notification Number B/NL/22/007 Member State to which the notification was sent Netherlands Date of acknowledgement from the Member State Competent Authority 18/07/2022 Title of the Project A phase I/II trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive patients with relapsed or refractory NPM1-mutated AML Proposed period of release: 01/10/2022 to 31/12/2026 Name of the Institute(s) or Company(ies) Leiden University Medical Center, Albinusdreef 2 2333 ZA Leiden PO Box 9600 2300 RC Leiden The Netherlands
Is the same GMO been notified elsewhere by the same notifier? Yes:
Germany;
Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: Other Identity of the GMO: T cells transduced with a replication-deficient lentiviral vector harbouring the T cell receptor recognizing dNPM1 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: Yes
07/27/2022
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