研究概要
这些初步结果表明,所提出的细胞疗法可考虑在临床试验中进一步研究。
研究思路结论见上方概要
背景
本研究介绍了关于一种新型免疫疗法在癌症中有效性的初步结果。所提出的过继性细胞治疗产品包含效应免疫细胞的混合物,具体为巨噬细胞、NK细胞、树突状细胞、细胞毒性T淋巴细胞和产生单克隆抗体的浆细胞。
方法
结果基于对17例癌症患者数据的描述性和推断性统计分析。特别是,在治疗后(4个月)评估了临床状况、Karnofsky指数、ECOG指数和症状量表等性能量表。此外,在细胞治疗前后测量了循环肿瘤细胞(CTCs)和特定肿瘤标志物(EpCAM)。
结果
结果显示,临床状况(70.59 %)、Karnofsky-Index(88.23 %)、ECOG index(94.12 %)和症状量表(64.70 %)均获得积极评价。此外,治疗后CTC(p = 0.0016)和EpCAM阳性细胞(p = 0.0005)均出现统计学显著减少,分别与0.77和0.85的大效应量相关。在4个月的随访评估中,未观察到细胞因子风暴、过敏反应或严重不良事件。
展开英文摘要原文
BACKGROUND: This study presents preliminary results concerning the effectiveness of a novel immunotherapy in cancer. The proposed adoptive cellular therapy product contains a mixture of effector immune cells, specifically macrophages, NK cells, dendritic cells, cytotoxic T lymphocytes and monoclonal antibody producing plasma cells.
METHODS: The results were based on both descriptive and inferential statistical analysis of data concerning 17 cancer patients. Particularly, performance scales such as clinical condition, Karnofsky-Index, ECOG index and symptom's scale were evaluated post therapy administration (4 months). Furthermore, circulating tumor cells (CTCs) and a specific tumor marker (EpCAM) were measured pre- and post-cellular therapy.
RESULTS: The results revealed a positive evaluation for clinical condition (70.59 %), Karnofsky-Index (88.23 %), ECOG index (94.12 %), and symptoms' scale (64.70 %). In addition, statistically significant reductions were found for both CTCs (p = 0.0016) and EpCAM positive cells (p = 0.0005), post-therapy, which were related to large size effects, namely 0.77 and 0.85, respectively. No cytokine storm, anaphylaxis or severe adverse events were observed with 4 months follow up evaluation.
CONCLUSIONS: These preliminary results indicate that the proposed cellular therapy can be considered for further studies in clinical trials.
论文信息
- 作者
- Parsonidis P、Beis G、Iliopoulos AC、Papasotiriou I
- 第一作者单位
- Research Genetic Cancer Centre S.A., Florina, Greece.Greece
- 通讯作者单位
- Research Genetic Cancer Centre International GmbH, Zug, Switzerland. Electronic address: papasotiriou.ioannis@rgcc-international.com.Switzerland
- 期刊
- Cellular immunology2022 Dec