Definition

A preparation of autologous T lymphocytes that have been genetically modified to express a chimeric antigen receptor (CAR) consisting of a single chain variable fragment (scFv) of anti-CD19 coupled to as of yet not fully elucidated co-stimulatory molecules, with potential immunostimulating and antineoplastic activities. Upon transfusion, autologous CD19-targeted CAR-T cells GC007F target and bind to CD19-expressing neoplastic B cells. This results in a cytotoxic T-lymphocyte (CTL) response against CD19-expressing tumor cells, the release of cytotoxic molecules and the induction of tumor cell lysis. CD19, cluster of differentiation 19, is a B-cell-specific cell surface antigen overexpressed in B-cell lineage tumors. The processing platform used, FasT (F) CAR-T, shortens the manufacturing time to produce the CAR-T cells within 24 hours.