Cheng Xiaobo, Wang Jing, Qiu Chenli, Jin Yanling, Xia Bili, Qin Ran, Hu Huiliang, Yan Jia, Zhang Xiaoyan, Xu Jianqing
Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Fudan University, Shanghai 201508, P.R. China; Clinical Research Center, Obstetrics & Gynecology Hospital of Fudan University, Shanghai 200011, P.R. China.
Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Fudan University, Shanghai 201508, P.R. China.
Clin Immunol. 2022 May;238:108992. doi: 10.1016/j.clim.2022.108992. Epub 2022 Mar 30.
We performed a single-arm exploratory clinical trial that is ongoing and registered at ClinicalTrials.gov (NCT03093688). Patients were infused with autologous iNKT cells, PD-1 + CD8+ T cells, and dendritic cells every 3-5 weeks, which was considered 1 cycle. The primary endpoints were safety and objective tumor response. The preliminary results from the first three patients are reported here. The first patient received 16 cycles. Computed tomography (CT) examination revealed a stable disease (SD) response after 4 cycles and progressive disease (PD) response after 11 cycles. For the second patient that received 10 cycles, CT examination revealed an SD response after 4 cycles and a PD response after 9 cycles. For the third patient who was treated with 6 cycles, CT examination revealed an SD response after 4 cycles. The patients suffered from only grade 1-2 adverse events. iNKT cell and PD-1 + CD8+ T cell-based immunotherapy showed a manageable tolerability profile.
我们开展了一项正在进行的单臂探索性临床试验，并已在ClinicalTrials.gov（NCT03093688）上注册。患者每3 - 5周接受一次自体不变自然杀伤T细胞、程序性死亡蛋白1（PD-1）+ CD8 + T细胞和树突状细胞的输注，这被视为1个周期。主要终点为安全性和客观肿瘤反应。本文报告了前三位患者的初步结果。第一位患者接受了16个周期的治疗。计算机断层扫描（CT）检查显示，在4个周期后出现疾病稳定（SD）反应，在11个周期后出现疾病进展（PD）反应。第二位接受10个周期治疗的患者，CT检查显示在4个周期后出现SD反应，在9个周期后出现PD反应。第三位接受6个周期治疗的患者，CT检查显示在4个周期后出现SD反应。患者仅出现1 - 2级不良事件。基于不变自然杀伤T细胞和PD-1 + CD8 + T细胞的免疫疗法显示出可管理的耐受性。
