Definition

A preparation of autologous T-lymphocytes that have been genetically modified to express a chimeric antigen receptor (CAR) specific for the tumor-associated antigen (TAA) and immune checkpoint protein human leukocyte antigen G (HLA-G), with potential immune checkpoint inhibiting, immunomodulating and antineoplastic activities. Upon administration, autologous anti-HLA-G CAR-T cells IVS-3001 specifically recognize and kill HLA-G-expressing tumor cells. This reverts HLA-G-mediated immune suppression in the tumor microenvironment (TME), thereby restoring anti-tumor immune responses. HLA-G, an immune checkpoint normally expressed at the maternal-fetal interface, is expressed across multiple tumor types and plays a key role in cancer immune evasion. It inhibits immune responses by binding to its inhibitory receptors on a variety of immune cells, such as natural killer cells (NKs), T- and B-lymphocytes, and dendritic cells (DCs).