Definition

An off-the-shelf (OTS) preparation of human allogeneic T lymphocytes containing primarily stem cell memory T cells (Tscm) that have been genetically modified to express a chimeric antigen receptor (CAR) specific for the C-terminal subunit of the tumor-associated antigen (TAA) mucin-1 (MUC1-C) and gene-edited to knockout both the T-cell receptor (TCR) and major histocompatibility complex (MHC) class I proteins, with potential immunostimulating and antineoplastic activities. Upon administration, allogeneic MUC1-C-specific CAR-T cells P-MUC1C-ALLO1 specifically recognize and induce selective toxicity in MUC1-C-expressing tumor cells. MUC1, a glycoprotein normally expressed on epithelial cells and overexpressed on the surface of a variety of cancer cells, plays a key role in tumor cell survival and proliferation. The proteolytic cleavage of MUC1 in the tumor microenvironment (TME) leads to the overexpression of MUC1-C in the TME.