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Full notification
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General information Notification NumberB/ES/23/17Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority11/07/2023Title of the ProjectA Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS 986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE), trial number CA061-1001Proposed period of release:01/10/2023 to 30/04/2027Name of the Institute(s) or Company(ies)Celgene Corporation, 86 Morris Avenue, Summit, New Jersey 07901 Is the same GMO been notified elsewhere by the same notifier? Yes: Belgium; Germany; France; Italy; Has the same GMO been notified elsewhere by the same notifier?No
GMO characterization GMO is a: OtherIdentity of the GMO: The GMO CC-97540 (also known as BMS-986353) consists of autologous Homo sapiens T cells transduced with a lentiviral vector (LVV) which encodes an anti-CD19 Chimeric Antigen Receptor (CAR) directed against CD19-expressing cells. CC-97540 is a second-generation CAR T cell construct comprised of autologous CD3+ T cells expressing a CD19-specific CAR consisting of a single chain variable fragment (scFv) binding domain sequence isolated from a murine CD19-specific hybridoma cell line (FMC63), fused in sequence to the IgG4 hinge, the CD28 transmembrane, the 4-1BB and CD3ΞΆ (zeta) chain signaling domains. A non-functional truncated epidermal growth factor receptor (EGFRt) is also co-expressed with the CD19-specific CAR via a self-cleaving peptide.Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Genus: HomoSpecies: Homo SapiensSubspecies: Strain: Pathovar:
European Commission administrative Information Consent given by the Member State Competent Authority: Yes 11/14/2023