Ongoing complete remissions (CR) in the phase 1 of ZUMA-1: a phase 1-2 multicenter study evaluating the safety and efficacy of KTE-C19 (anti-CD19 CAR T cells) in subjects with refractory aggressive B-cell Non-Hodgkin Lymphoma (NHL).

7559This study is supported in part by The Leukemia & Lymphoma Society Therapy Acceleration Program Background: Durable remissions with CD28/CD3z anti-CD19 CAR T cells have been observed in patients with relapsed/refractory B cell malignancies at the NCI (Kochenderfer, JCO 2015; NCT00924326). KTE-C19 utilizes the same CAR construct as the NCI trial, but is centrally manufactured in a streamlined 6 - 8 day process. We present updated data from the phase 1 portion of ZUMA-1. Methods: KTE-C19 was administered at a target dose of 2 x 106 anti-CD19 CAR T cells/kg after a fixed dose of cyclophosphamide/fludarabine conditioning chemotherapy (Locke, ASH 2015). The primary objective was to evaluate the safety of KTE-C19. Secondary objectives were to evaluate the overall response rate, duration of response, levels of CAR T cells in the blood, and levels of serum cytokines. Key inclusion criteria were ECOG 0-1 and chemotherapy-refractory disease defined as progressive disease or stable disease as best response to la...