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ORVACABTAGEN AUTOLEUCEL
AUTOLOGOUS CD4+ AND CD8+ T LYMPHOCYTES OBTAINED FROM PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC), TRANSDUCED EX VIVO WITH A REPLICATION-INCOMPETENT, SELFINACTIVATING (SIN) LENTIVIRAL VECTOR, ENCODING A CHIMERIC ANTIGEN RECEPTOR (CAR) CONSISTING OF THE HUMAN B CELL MATURATION ANTIGEN (BCMA)-SPECIFIC SCFV, AN LGG4- CH2-CH3 HINGE REGION, CD28 TRANSMEMBRANE DOMAIN, CD137 (4-1BB) CO-STIMULATORY DOMAIN AND CD3 ZETA SIGNALLING DOMAIN, UNDER THE CONTROL OF A HYBRID ELONGATION FACTOR 1 ALPHA (EF1 ALPHA) / HUMAN T CELL LEUKEMIA VIRUS (HTLV) R ELEMENT PROMOTER. THE VECTOR ALSO ENCODES A TRUNCATED HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (EGFRT) THAT IS EXPRESSED SEPARATELY FROM THE CAR ON THE CELL SURFACE; REC. INN LIST 84