Modified Manufacturing Process Modulates CD19CAR T-cell Engraftment Fitness and Leukemia-Free Survival in Pediatric and Young Adult Subjects

浏览次数:2 分享:

Francesco Ceppi #, Ashley L Wilson #, Colleen Annesley, Gabriella R Kimmerly, Corinne Summers, Adam Brand, Kristy Seidel, Qian Vicky Wu, Adam Beebe, Christopher Brown, Stephanie Mgebroff, Catherine Lindgren, Stephanie D Rawlings-Rhea, Wenjun Huang, Michael A Pulsipher, Alan S Wayne, Julie R Park, Michael C Jensen, Rebecca A Gardner

  • Clinical Trial
  • 2.2
  • 2022 Jul 1;10(7):856-870.
  • Human,Rhesus,Cynomolgus,Baboon,Dog
  • 流式
  • 循环系统
  • 循环系统
  • T细胞
  • 白血病
  • CD14,CD3,CD36,CD4,CD45RA,CD45RO,CD8,CD95,IFN-γ,LAG-3 (CD223)
  • doi: 10.1158/2326-6066.CIR-21-0501.

Abstract

T cells modified to express a chimeric antigen receptor (CAR) targeting CD19 can induce potent and sustained responses in children with relapsed/refractory acute lymphoblastic leukemia (ALL). The durability of remission is related to the length of time the CAR T cells persist. Efforts to understand differences in persistence have focused on the CAR construct, in particular the costimulatory signaling module of the chimeric receptor. We previously reported a robust intent-to-treat product manufacturing success rate and remission induction rate in children and young adults with recurrent/refractory B-ALL using the SCRI-CAR19v1 product, a second-generation CD19-specific CAR with 4-1BB costimulation coexpressed with the EGFRt cell-surface tag (NCT02028455). Following completion of the phase I study, two changes to CAR T-cell manufacturing were introduced: switching the T-cell activation reagent and omitting midculture EGFRt immunomagnetic selection. We tested the modified manufacturing process and resulting product, designated SCRI-CAR19v2, in a cohort of 21 subjects on the phase II arm of the trial. Here, we describe the unanticipated enhancement in product performance resulting in prolonged persistence and B-cell aplasia and improved leukemia-free survival with SCRI-CAR19v2 as compared with SCRI-CAR19v1.
金课堂之文献解析 文献原文请点击

技术文章 更多

    研究领域 更多

      热点文献