NCIt definition : A preparation of autologous CD4- and CD8-positive T-lymphocytes that have been transduced
with a lentiviral vector (LV) expressing a chimeric antigen receptor (CAR) specific
for the human tumor-associated antigen (TAA) CD19 that is fused to the intracellular
cytoplasmic domain of 4-1BB (CD137) and the zeta chain of the TCR/CD3 complex (CD3zeta),
and linked to a truncated form of the human epidermal growth factor receptor 2 (HER2tG),
with potential immunostimulating and antineoplastic activities. Upon administration,
the autologous anti-CD19CAR-4-1BB/CD3zeta-HER2tG-expressing CD4 /CD8 T-lymphocytes
SCRI-huCAR19v2 specifically target and bind to CD19-expressing neoplastic B-cells.
This results in a cytotoxic T-lymphocyte (CTL) response against CD19-expressing tumor
cells and causes tumor cell lysis. CD19 is a B-cell-specific cell surface antigen
that is overexpressed in B-cell lineage tumors. Incorporation of the costimulatory
signaling domain increases human T-cell function, expansion, and survival. Devoid
of both ligand binding domains and tyrosine kinase activity, the co-expressed HER2tG
both facilitates in vivo detection of the administered, transduced T-cells and can
promote elimination of those cells through a trastuzumab-induced antibody dependent
cellular cytotoxicity (ADCC) response.;