CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题：NEOadjuvant Dendritic cell therapy added to first line standard of care in advanced epithelial Ovarian Cancer (NEODOC): protocol of a first-in-human, exploratory, single-centre phase I/II trial in the Netherlands.
NEOadjuvant Dendritic cell therapy added to first line standard of care in advanced epithelial Ovarian Cancer (NEODOC): protocol of a first-in-human, exploratory, single-centre phase I/II trial in the Netherlands.
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目前可用的免疫疗法在晚期上皮性卵巢癌（EOC）患者中未能达到诱导持久缓解的预期。EOC中体细胞错义突变数量较少，因此需要高效力的新抗原导向方法。为此，我们开发了一种新型树突状细胞（DC）产品，由DC中专门负责交叉呈递的亚群——传统DC 1型（cDC1）组成。方法与分析：我们将开展NEODOC研究，这是一项由研究者发起的首次人体I/II期试验。该研究将评估基于cDC1、负载自体肿瘤裂解物的DC产品的免疫原性、安全性和可行性。10例既往未治疗的晚期EOC患者（IIIb-c期、IVa期，或若仅有膈上或腹股沟淋巴结<1 cm则为IVb期）需要新辅助化疗，将接受DC治疗，同时接受标准治疗的卡铂/紫杉醇化疗和间隔减瘤手术。主要终点是免疫反应，次要终点是治疗的安全性和可行性以及临床疗效。伦理与传播：本试验已获得荷兰中央人体研究伦理委员会的伦理批准。结果将通过在国际开放获取科学期刊上发表论文和在科学会议上作报告进行传播。
INTRODUCTION: The currently available immunotherapies have failed to meet expectations in inducing durable responses in patients with advanced epithelial ovarian cancer (EOC). The low number of somatic missense mutations in EOC necessitates highly potent neoantigen-directed approaches.
To this end, we have developed a novel dendritic cell (DC) product that consists of a specialised cross-presenting subset of DC, conventional DC type 1 (cDC1). METHODS AND ANALYSIS: We will conduct the NEODOC study, an investigator-initiated first-in-human phase I/II trial.
This study will assess the immunogenicity, safety and feasibility of a cDC1-based, autologous tumour lysate-loaded, DC product. 10 patients with previously untreated advanced EOC (stage IIIb-c, IVa or stage IVb if only supradiaphragmatic or inguinal lymph nodes <1 cm) requiring neoadjuvant chemotherapy will receive DC therapy alongside standard-of-care carboplatin/paclitaxel chemotherapy and interval cytoreductive surgery.
The primary endpoint is immune response, and the secondary endpoints are the safety and feasibility of the treatment as well as clinical efficacy. ETHICS AND DISSEMINATION: Ethical approval for this trial was granted by the Netherlands Central Committee on Research Involving Human Subjects. The results will be disseminated through publications in international, open-access scientific journals and presentations at scientific conferences. TRIAL REGISTRATION NUMBER: NCT05773859; EUCT number 2024-512353-24-01.
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