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A phase I study of loco-regional immunotherapy by transbronchial injection of α-galactosylceramide-pulsed antigen presenting cells in patients with lung cancer.
Clinical Immunology ( IF 4.5 ) Pub Date : 2020-05-06 , DOI: 10.1016/j.clim.2020.108457
Fumihiro Ishibashi 1 , Yuichi Sakairi 2 , Takekazu Iwata 2 , Yasumitsu Moriya 2 , Teruaki Mizobuchi 2 , Hidehisa Hoshino 2 , Shigetoshi Yoshida 3 , Hideki Hanaoka 4 , Ichiro Yoshino 2 , Shinichiro Motohashi 5
Affiliation  

We conducted a phase I study of the trans-bronchial injection of α-galactosylceramide (αGalCer)-pulsed antigen presenting cells (APCs) to evaluate their safety, immune responses, and anti-tumor activities. Patients with advanced or recurrent non-small cell lung cancer (NSCLC) refractory to standard treatments were eligible. αGalCer-pulsed APCs were administered intratumorally or intranodally by bronchoscopy. Twenty-one patients were enrolled in this study. No severe adverse events related to the cell therapy were observed during this study in any patient. After αGalCer-pulsed APCs were administrated, increased iNKT cell numbers were observed in PBMCs from eight cases, and IFN-γ producing cells were increased in the peripheral blood of 10 cases. Regarding clinical responses, one case exhibited a partial response and eight were classified as stable disease. In the tumor microenvironment, IFN-γ expression was upregulated after treatment in partial response or stable disease cases and TGF-β was upregulated in progressive disease cases.

中文翻译:

肺癌患者经支气管注射α-半乳糖基神经酰胺刺激的抗原呈递细胞进行局部区域免疫治疗的I期研究。

我们进行了经支气管注射α-半乳糖基神经酰胺(αGalCer)脉冲的抗原呈递细胞(APC)的I期研究,以评估其安全性,免疫应答和抗肿瘤活性。患有标准治疗难以治疗的晚期或复发性非小细胞肺癌(NSCLC)患者。通过支气管镜检查在瘤内或结节内给予αGalCer脉冲的APC。本研究招募了21名患者。在本研究中,任何患者均未观察到与细胞治疗相关的严重不良事件。施用αGalCer脉冲的APC后,发现8例PBMC中iNKT细胞数量增加,而10例外周血中产生IFN-γ的细胞增加。关于临床反应,1例表现出部分反应,8例归为稳定疾病。在肿瘤微环境中,在部分缓解或稳定疾病病例中,治疗后IFN-γ表达上调,而在进行性疾病病例中,TGF-β表达上调。
更新日期:2020-05-06
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