C‐ CAR066 , a novel fully human anti‐ CD20 CAR ‐T therapy for relapsed or refractory large B‐cell lymphoma after failure of anti‐ CD19 CAR ‐T therapy: A phase I clinical study

作者：Ping Li, Wei Liu, Lili Zhou, Shiguang Ye, Dan Zhu, Jiaqi Huang, Jing Li, Chengxiao Zheng, Shigui Zhu, Xin Yao, Kevin Zhu, Yihong Yao, Lugui Qiu, Aibin Liang, Dehui Zou · 发表于：American Journal of Hematology · 年份：2024 · DOI：10.1002/ajh.27488 · 被引用次数：9 · 研究领域：CAR-T cell therapy research、Advancements in Semiconductor Devices and Circuit Design、Integrated Circuits and Semiconductor Failure Analysis

Abstract Managing large B‐cell lymphoma (LBCL) that is refractory to or relapsed after chimeric antigen receptor (CAR)‐T therapy remains a significant challenge. Here we aimed to investigate the safety and efficacy of C‐CAR066, an autologous fully human anti‐CD20 specific CAR‐T, for relapsed/refractory LBCL after failure of anti‐CD19 CAR‐T therapy. This first‐in‐human, single‐arm, phase 1 study was conducted at two sites in China. Eligible patients had to be histologically confirmed with CD20‐positive LBCL and must have received prior anti‐CD19 CAR‐T therapy. Patients received a single intravenous infusion of C‐CAR066 at a target dose of 2.0 × 10 6 or 3.0 × 10 6 CAR‐T cells/kg. The primary endpoint was the incidence of adverse events (AEs). As of October 10, 2023, 14 patients had received C‐CAR066. The most common AEs of Grade 3 or higher were hematological toxicities. Cytokine release syndrome occurred in 12 (85.7%) patients, with only one was Grade 4 event. No patient experienced immune effector cell‐associated neurotoxicity syndrome events. The overall response rate was 92.9% with a complete response rate of 57.1%. With a median follow‐up of 27.7 months (range, 3.3–40.9), the median progression‐free survival and overall survival were 9.4 months (95% CI, 2.0 to NA) and 34.8 months (95% CI, 7.5 to NA), respectively. C‐CAR066 demonstrated a manageable safety profile and promising efficacy in patients in whom prior anti‐CD19 CAR‐T therapies had failed, providing a promising tr...