CELL INTELLIGENCE · 肿瘤细胞治疗研究

CELLIN 肿瘤细胞治疗研究

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自体细胞因子诱导的杀伤细胞联合信迪利单抗（抗程序性细胞死亡-1 单克隆抗体）加化疗治疗晚期非小细胞肺癌患者的 IB 期试验

英文原题：A Phase IB Trial of Autologous Cytokine-Induced Killer Cells in Combination with Sintilimab, Monoclonal Antibody Against Programmed Cell Death-1, plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer.

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A Phase IB Trial of Autologous Cytokine-Induced Killer Cells in Combination with Sintilimab, Monoclonal Antibody Against Programmed Cell Death-1, plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer.

PubMed 2022/07/21（内容时间） Clin Lung Cancer Q2 · IF 3.9（JCR 2025）

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非小细胞肺癌地区：中国
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研究概要

自体 CIK 细胞免疫治疗联合信迪利单抗加化疗在既往未治疗的晚期 NSCLC 患者中耐受性良好，并显示出令人鼓舞的疗效（ClinicalTrials.gov 注册号，NCT03987867）。

中文摘要

患者与方法

IIIB/IIIC/IV期患者每3周接受信迪利单抗、铂类双药化疗和CIK细胞，共4个周期；随后，鳞癌患者接受信迪利单抗维持治疗，非鳞癌患者接受信迪利单抗联合培美曲塞维持治疗，直至疾病进展、出现不可接受毒性或治疗满2年。主要终点为安全性和客观缓解率（ORR）。

结果

34例患者接受治疗。94.1%发生治疗相关不良事件（TRAE），64.7%发生≥3级TRAE；1例（2.9%）死于5级免疫相关肺炎。ORR为82.4%（95% CI 65.5%–93.2%），疾病控制率为100.0%（95% CI 89.7%–100.0%）。非鳞癌患者15例中14例客观缓解（93.3%；95% CI 68.1%–99.8%），鳞癌患者19例中14例缓解（73.7%；95% CI 48.8%–90.9%）。中位无进展生存期（PFS）为19.3个月（95% CI 8.3个月至不可估计）。

结论

自体CIK细胞免疫治疗联合信迪利单抗和化疗在未经治疗的晚期NSCLC患者中耐受性良好，并显示出令人鼓舞的疗效。ClinicalTrials.gov注册号：NCT03987867。

展开英文摘要原文
PATIENTS AND METHODS

Patients with stage IIIB/IIIC/IV NSCLC received Sintilimab, platinum-based doublet chemotherapy, and CIK cells every 3 weeks for 4 cycles, then maintenance treatment with Sintilimab in squamous and with Sintilimab plus pemetrexed in non-squamous NSCLC until disease progression or unacceptable toxicity or 2 years. The primary endpoints were safety and objective response rate (ORR).

RESULTS

Thirty-four patients received the treatment. 94.1% of patients experienced treatment-related adverse events (TRAEs). Grade 3 or greater TRAEs occurred in 64.7% of patients. One (2.9%) patient died of grade 5 immune-related pneumonia. The ORR and DCR were 82.4% (95% CI, 65.5%-93.2%) and 100.0% (95% CI, 89.7%-100.0%), respectively. Objective responses were evaluated in 14 of 15 non-squamous patients (93.3%; 95% CI, 68.1%-99.8%) and in 14 of 19 squamous patients (73.7%; 95% CI, 48.8%-90.9%). Median PFS was 19.3 months (95% CI, 8.3 months to not available).

CONCLUSION

Autologous CIK cells immunotherapy in combination with Sintilimab plus chemotherapy was well tolerable and showed encouraging efficacy in patients with previously untreated, advanced NSCLC (ClinicalTrials.gov number, NCT03987867).

论文信息

作者
Zhou L、Xiong Y、Wang Y、Meng Y、Zhang W、Shen M、Zhang X、Li S
第一作者单位
Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China; Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin 300060, China; Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China; Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin 300060, China.China
通讯作者单位
Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China; Department of Immunology, Tianjin Medical University Cancer Institute and Hospital, Tianjin 300060, China; Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin 300060, China; Tianjin's Clinical Research Center for Cancer, Tianjin 300060, China; Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin 300060, China. Electronic address: renxiubao@tjmuch.com.China
文献类型
I 期临床试验 · 非美国政府资助研究
期刊
Clinical lung cancer2022 Dec
原文标识
PubMed 35995696　·　DOI 10.1016/j.cllc.2022.07.009

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