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

Phase 1/2 · 2017 · Diffuse Large B-Cell Lymphoma, Primary Mediastinal B-Cell Lymphoma, Transformed Follicular Lymphoma

Design

Single-arm, multicenter study of a single infusion of anti-CD19 CAR T cells after conditioning chemotherapy in relapsed/refractory aggressive B-cell NHL.

Population

Adults with refractory large B-cell lymphoma (no response to last chemo or relapse within 12 months of autologous transplant).

Primary Endpoint

objective response rate (ORR)

Key Result

ORR 82% with complete response 54%; at long-term follow-up ~40% remained in ongoing response and median overall survival exceeded 2 years.

Guideline Impact

NCCN-preferred CAR T-cell therapy for relapsed/refractory LBCL