Furthermore, based on our tumor microenvironment (TME) studies, ITI-1001-treated tumors showed significant CD4 T-cell infiltration and activation and enhanced activation of CD8 T cytotoxic killer cells, along with an increase in Natural Killer T (NKT) cells thereby providing possible clues into the mechanism(s) of action of ITI-1001. Here, CD4 is linked to neoplasm.