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Full notification Final report - General information Notification Number B/ES/22/22 Member State to which the notification was sent Spain Date of acknowledgement from the Member State Competent Authority 29/07/2022 Title of the Project Phase 2 study of the infusion of differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z (ARI-0001 cells) in children and adolescents aged 0-18 years with CD19+ acute lymphoid leukemia resistant or refractory to therapy.  Proposed period of release: 01/11/2022 to 30/11/2025 Name of the Institute(s) or Company(ies) Fundació privada per a la Recerca i la docència Sant Joan de Déu (FSJD)
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: Identity of the GMO (genus and species): T lymphocytes from patients aged 0-18 years with acute lymphoblastic leukemia (Homo sapiens sapiens) transduced with the self-inactivating lentiviral vector pCCL to express the chimeric synthetic receptor with anti-CD19 specificity (A3B1), which has been conjugated with 4-1BB as co-stimulatory domain and CD3 as signaling domain (ARI0001 cells).  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
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