Definition

A preparation of human allogeneic T lymphocytes that are gene-edited with the clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9 nuclease complex to disrupt the expression of endogenous T-cell receptor (TCR) alpha and to express a dimeric antigen receptor (DAR) composed of a fragment antigen-binding variable region (Fab) recognizing the tumor-associated antigen (TAA) cluster of differentiation 38 (CD38), linked to the intracellular signaling domains of 4-1BB (CD137) and the zeta chain of the TCR/CD3 complex (TCRzeta; CD247; CD3zeta), with potential immunomodulating and antineoplastic activities. Upon intravenous administration, allogeneic anti-CD38 DAR-T cells STI-1492 are directed to and induce selective toxicity in CD38-expressing tumor cells. CD38, a type II transmembrane glycoprotein, is present on various immune cells and hematologic malignancies, and its expression has been correlated with poor prognosis. The disruption of endogenous TCR alpha prevents graft-versus-host disease (GvHD).