NCIt definition : A preparation of a defined ratio of CD4 and bulk CD8 autologous T-lymphocytes transduced
with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing a
human anti-CD19 single chain variable fragment (scFv) fused to the signaling domain
of 4-1BB (CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated
form of the human epidermal growth factor receptor (EGFRt), with potential immunostimulating
and antineoplastic activities. Upon intravenous administration, autologous human anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing
CD4 /CD8 T-lymphocytes are directed to and induce selective toxicity in CD19-expressing
tumor cells. CD19 antigen is a B-cell specific cell surface antigen expressed in all
B-cell lineage malignancies. Devoid of both ligand binding domains and tyrosine kinase
activity, the expressed EGFRt both facilitates in vivo detection of the administered,
transduced T-cells and can promote elimination of those cells through a cetuximab-induced
antibody dependent cellular cytotoxicity (ADCC) response. The 4-1BB costimulatory
signaling domain enhances both proliferation of T-cells and antitumor activity.;