Pilot study of T cells redirected to EGFRvIII with a chimeric antigen receptor in patients with EGFRvIII+ glioblastoma.

Abstract

2067Background: We have developed an autologous T cell product directed to the EGFR variant III mutation via lentiviral transduction of a chimeric antigen receptor (CAR), and opened an IND. We have initiated a pilot study enrolling patients with recurrent EGFRvIII-positive glioblastoma (GBM). Methods: Patients with recurrent GBM have their tumors screened for the presence of the EGFRvIII mutation by a next-generation sequencing based assay. Eligible patients undergo leukapheresis for collection of autologous T cells, which are genetically modified ex vivo to express the EGFRvIII CAR, expanded, and then cryopreserved for infusion. Results: We report results on the nine patients we have treated. To date, we have found that infusion of 1-5x108 CART-EGFRvIII cells is feasible to manufacture and infusion is safe, without evidence of off-tumor toxicity or cross-reactivity to wild type EGFR. No clinical or laboratory signs of systemic cytokine release syndrome have been observed, though elevations in serum IL-6 ...