Definition

A preparation of autologous T lymphocytes that have been genetically modified to express a chimeric antigen receptor (CAR) specific for glypican-3 (GPC3) and a signal activation domain element, Ori, with potential immunostimulating and antineoplastic activities. Upon administration, autologous anti-GPC3-CAR T lymphocytes Ori-C101 specifically target and bind to GPC3-expressing tumor cells, resulting in tumor cell lysis. GPC3, a heparan sulfate proteoglycan (HSPG) and a member of the glypican family, is overexpressed on certain tumor cell types while minimally expressed on normal, healthy cells. GPC3 plays an important role in cellular proliferation and differentiation. Ori is able to enhance the expansion of memory T cells, abrogate the immunosuppressive tumor microenvironment (TME), and may enhance the anti-tumor activity and durability of CAR T cells Ori-C101.