Definition

A preparation of autologous T lymphocytes that have been transduced with a retroviral vector expressing a chimeric antigen receptor (CAR) containing a single chain variable fragment (scFv) specific for the tumor-associated antigen (TAA) human G-protein coupled receptor family C group 5 member D (GPRC5D) and the co-stimulatory domain 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. Upon leukapheresis, isolation, transduction, expansion ex vivo, and reintroduction into the patient, the autologous anti-GPRC5D-CAR-4-1BB-expressing T cells MCARH109 specifically recognize and induce selective toxicity in GPRC5D-expressing tumor cells. GPRC5D is overexpressed in certain malignancies, such as multiple myeloma, while minimally expressed in normal, healthy cells. It plays a key role in tumor cell proliferation.