肿瘤细胞治疗研究
英文原题：Clinical Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of ATC
Clinical Study of NKG2D CAR-NK Combined with PD-1 Monoclonal Antibody in the Treatment of ATC
⚠ 该试验的登记信息已有 19 个月未更新， 页面上显示的「尚未开始招募」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I/II 期注册临床试验，评估 CAR-NK 细胞治疗相关疾病的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 30 例。试验地点：中国 · 杭州（共 1 个中心，其中中国 1 个）。登记号：NCT06856278。
不限性别 · ≥ 18 Years 且 ≤ 75 Years
纳入标准： 1. 年龄18至75岁（含界值），男性或女性。 2. 经组织病理学诊断为间变性甲状腺癌，且至少有一个≥1 cm的可测量病灶。 3. 肝肾功能良好，能够耐受治疗。 4. 能够配合完成治疗和随访。 5. 无其他全身性疾病，包括其他恶性肿瘤。 排除标准： 1. 需要哺乳或有生育计划。 2. 患有免疫系统疾病。 3. 患有血液系统疾病。 4. 患有精神系统疾病。 5. 患有间质性肺炎、肺部疾病等。 6. 未能遵守本研究要求。
Inclusion Criteria: 1. Age 18-75 years (including boundary values), male or female. 2. Be diagnosed with anaplastic thyroid cancer histopathologically with a measurable lesion≥1cm. 3. Liver and kidney function is good, and can tolerate treatment. 4. Be able to cooperate with the completion of treatment and follow-up work. 5. No other systemic diseases, including other malignancies. Exclusion Criteria: 1. Need to breastfeed the baby or have fertility needs； 2. Immune system diseases; 3. Diseases of the blood system; 4. Mental system diseases; 5. Interstitial pneumonia, lung disease, etc.; 6. Failure to follow rules of this study.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Safety and tolerability · Safety and tolerability at 28 days after combination therapy, dose limiting toxicity (DLT) and maximum tolerated dose (MTD) were determined. · From the start of the trial to day 56 after the first infusion of CAR-NK.
本研究对间变性甲状腺癌患者给予CAR-NK免疫细胞联合PD-1单克隆抗体治疗，并观察和评估患者的安全性及耐受性。
The patients with anaplastic thyroid cancer were treated with CAR-NK immune cells combined with PD-1 monoclonal antibody, and the safety and tolerability of the patients were observed and evaluated.
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