Definition

A preparation of autologous CD4- and CD8-positive T lymphocytes that have been ex vivo transduced with a genetically-engineered lentiviral vector (LV) expressing a chimeric antigen receptor (CAR) containing a single chain variable fragment (scFv) specific for the tumor-associated antigen (TAA) human B-cell maturation antigen (BCMA; tumor necrosis factor receptor superfamily member 17; TNFRSF17) fused to the co-stimulatory domain of 4-1BB (CD137) and the CD3-zeta (CD3z) T-cell signaling domain, with potential immunostimulating and antineoplastic activities. Upon administration, autologous anti-BCMA-CAR-4-1BB-CD3zeta-expressing CD4+/CD8+ T lymphocytes JCARH125 specifically recognize and induce selective toxicity in BCMA-expressing tumor cells. BCMA, a tumor-specific antigen and a receptor for both a proliferation-inducing ligand (APRIL) and B-cell activating factor (BAFF), is a member of the tumor necrosis factor receptor superfamily (TNFRSF) and plays a key role in plasma cell survival. BCMA is found on the surfaces of plasma cells and overexpressed on malignant plasma cells.