Melanoma and Sarcoma Medical Oncology Unit, State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou 510060, P.R. China.
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Bone and Soft Tissue Tumor, Peking University Cancer Hospital & Institute, 52 Fucheng Road, Beijing 100142, P.R. China.
Cell Rep Med. 2023 Aug 15;4(8):101133. doi: 10.1016/j.xcrm.2023.101133.
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/m/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).
新型抗 NY-ESO-1 特异性 TCR-T 细胞治疗用于 NY-ESO-1 阳性肿瘤有效，但 TCR-T 细胞治疗的安全、有效方案仍需进一步改善。本研究报告了一项针对 NY-ESO-1 的 TCR 亲和力增强型特异性 T 细胞治疗（TAEST16001）的 1 期临床试验。入组患者在接受环磷酰胺（15mg/kg/天×3 天）联合氟达拉滨（20mg/m/天×3 天）剂量减少的淋巴细胞耗竭后输注 TAEST16001 细胞，在过继转移后用低剂量白细胞介素-2 注射维持 TCR-T 细胞。12 例接受该方案治疗的患者分析显示，无治疗相关严重不良事件。总缓解率为 41.7%。中位无进展生存期为 7.2 个月，中位缓解持续时间为 13.1 个月。TAEST16001 细胞的方案为晚期软组织肉瘤患者提供了安全有效的治疗（ClinicalTrials.gov：NCT04318964）。
