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Full notification Final report - General information Notification Number B/DE/23/PEIP00492 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 20/06/2023 Title of the Project A 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 CA061-1001 Proposed period of release: 01/10/2023 to 30/04/2027 Name 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; Spain; France; Italy; Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: Other Identity 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 CD3ζ (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: Homo Species: Homo Sapiens Subspecies: N/A Strain: N/A Pathovar: N/A European Commission administrative Information Consent given by the Member State Competent Authority: Not known