NCIt definition : A preparation of a defined ratio of CD4 and CD8 autologous T-lymphocytes transduced
with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing an
anti-CD19 single chain variable fragment (scFv), derived from the CD19-specific murine
immunoglobulin (Ig) G1 monoclonal antibody FMC63, fused to the signaling domain of
CD28, 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, the autologous CD19 CAR
EGFRt CD4 and CD8 T-cells 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.;