JULIET — Study of Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 2 · 2019 · Diffuse Large B-Cell Lymphoma, Transformed Follicular Lymphoma

Design

Single-arm, international study of one infusion of anti-CD19 CAR T cells (tisagenlecleucel) after lymphodepleting chemotherapy.

Population

Adults with relapsed/refractory DLBCL after >=2 lines of therapy, ineligible for or relapsed after autologous stem-cell transplant.

Primary Endpoint

best overall response rate (ORR)

Key Result

ORR 52% with complete response 40%; relapse-free survival ~65% at 12 months among responders.

Guideline Impact

NCCN-listed CAR T-cell option for relapsed/refractory DLBCL