Autologous T cell therapy against CD19: Interim Phase I/II data

Interim data from 51 evaluable patients with refractory aggressive diffuse large B cell lymphoma (DLBCL) in the Phase II portion of the open-label, U.S. Phase I/II ZUMA-1 trial showed that a single IV infusion of 2x10 6 KTE-C19 cells/kg met the primary endpoint of improving ORR. Specifically, KTE-C19 led to an ORR of 76% and a complete remission (CR) rate of 47%. After 3 months of follow-up, the ORR fell to 39% and the CR rate to 33%. The trial enrolled patients with refractory DLBCL, primary mediastinal B cell lymphoma (PMBCL) or transformed follicular lymphoma to receive fludarabine and cyclophosphamide as a conditioning chemotherapy regimen followed by a single infusion of KTE-C19. In 11 evaluable patients with PMBCL or transformed follicular lymphoma in the Phase II portion of the trial, KTE-C19 led to an ORR of 91% and a CR rate of 73%. After 3 months of follow-up, the ORR and the CR rate both fell to 64%. ...