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iNKT 细胞和 PD-1+CD8+ T 细胞免疫治疗肺腺癌患者的可行性:一项 I/II 期临床试验的初步结果

英文原题:Feasibility of iNKT cell and PD-1+CD8+ T cell-based immunotherapy in patients with lung adenocarcinoma: Preliminary results of a phase I/II clinical trial.

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Feasibility of iNKT cell and PD-1+CD8+ T cell-based immunotherapy in patients with lung adenocarcinoma: Preliminary results of a phase I/II clinical trial.

PubMed 2022/03/30(内容时间) Clin Immunol Q2 · IF 4.1(JCR 2025)

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中文摘要

我们开展了一项单臂探索性临床试验,该试验正在进行中,并在ClinicalTrials.gov注册(NCT03093688)。患者每3-5周接受一次自体iNKT细胞、PD-1 + CD8+ T细胞和树突状细胞输注,视为1个周期。主要终点为安全性和客观肿瘤缓解。本文报告了前三例患者的初步结果。第一例患者接受了16个周期。计算机断层扫描(CT)检查显示,4个周期后为疾病稳定(SD)缓解,11个周期后为疾病进展(PD)缓解。第二例患者接受了10个周期,CT检查显示4个周期后为SD缓解,9个周期后为PD缓解。第三例患者接受了6个周期,CT检查显示4个周期后为SD缓解。患者仅发生1-2级不良事件。基于iNKT细胞和PD-1 + CD8+ T细胞的免疫治疗显示出可控的耐受性特征。

展开英文摘要原文

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.

论文信息

作者
Cheng X、Wang J、Qiu C、Jin Y、Xia B、Qin R、Hu H、Yan J
第一作者单位
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.China
通讯作者单位
Shanghai Public Health Clinical Center & Institutes of Biomedical Sciences, Fudan University, Shanghai 201508, P.R. China. Electronic address: xujianqing@fudan.edu.cn.China
文献类型
I 期临床试验 · II 期临床试验 · 非美国政府资助研究
期刊
Clinical immunology (Orlando, Fla.)2022 May
原文标识
PubMed 35367396 · DOI 10.1016/j.clim.2022.108992