Article
作者: Li, Yi ; Lau, Johnson Y N ; Wen, Xizhi ; Zhong, Shi ; Han, Zhaosheng ; Weng, Desheng ; Chen, Jiewen ; Lin, Yanmei ; Ou, Yusheng ; Liu, Jiayong ; Gong, Haiping ; Zhang, Xing ; Yang, Jing ; Peng, Ruiqing ; Chen, Aiyuan ; Ma, Ke ; Zeng, Lun ; Fan, Zhengfu ; Xu, Bushu ; Pan, Qiuzhong ; Que, Yi
New York esophageal squamous cell carcinoma-1 (NY-ESO-1)-specific T cell receptor (TCR) T cell therapy is effective in tumors with NY-ESO-1 expression, but a safe and effective TCR-T cell therapeutic protocol remains to be improved. Here, we report a phase 1 investigational new drug clinical trial with TCR affinity-enhanced specific T cell therapy (TAEST16001) for targeting NY-ESO-1. Enrolled patients receive TAEST16001 cell infusion after dose-reduced lymphodepletion with cyclophosphamide (15 mg/kg/day × 3 days) combined with fludarabine (20 mg/m2/day × 3 days), and the TCR-T cells are maintained with low doses of interleukin-2 injection post-adoptive transfer. Analysis of 12 patients treated with the regimen demonstrates no treatment-related serious adverse events. The overall response rate is 41.7%. The median progression-free survival is 7.2 months, and the median duration of response is 13.1 months. The protocol of TAEST16001 cells delivers a safe and highly effective treatment for patients with advanced soft tissue sarcoma (ClinicalTrials.gov: NCT04318964).