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：

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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。