Definition

A preparation of autologous human T lymphocytes expressing a chimeric antigen receptor (CAR) specific for the L1 cell adhesion molecule (L1CAM; L1-CAM; CD171) antigen and a truncated form of the human epidermal growth factor receptor (EGFRt), with potential immunostimulating and antineoplastic activities. Upon re-infusion into the patient, the autologous anti-L1CAM-CAR-EGFRt-expressing T cells are directed to and induce selective toxicity in L1CAM-expressing tumor cells. L1CAM, a neuronal cell adhesion molecule and member of the L1 protein family, plays a key role in the development of the nervous system; it is overexpressed in various tumor cell types and is associated with increased chemoresistance, tumor progression, migration and metastasis. Devoid of both ligand-binding domains and tyrosine kinase activity, EGFRt facilitates both the detection of the administered T cells in vivo and the elimination of the modified T cells following a cetuximab-induced antibody-dependent cellular cytotoxicity (ADCC) response.