肿瘤细胞治疗研究
英文原题：Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
Safety and Efficacy of Autologous NK Cell Adjuvant Therapy for Relapsed/Refractory Non-Hodgkin's B-cell Lymphoma
⚠ 该试验的登记信息已有 40 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，评估自体 NK 细胞治疗 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 33 例。试验地点：中国 · 湖北（共 1 个中心，其中中国 1 个）。登记号：NCT05909098。
不限性别 · ≥ 18 Years 且 ≤ 80 Years
纳入标准： 1. 年龄15至80岁，预期生存期超过6个月。 2. 病理确诊非霍奇金B细胞淋巴瘤，由三级甲等或更高级别医院病理检查确认，病理报告距今不足3年。 3. 首次确诊的复发/难治性非霍奇金B细胞淋巴瘤。 4. ECOG评分0至2。 5. 入组前CT至少有一个可测量病灶，最大横径≥1.5 cm。 6. 有生育能力女性入组前妊娠试验须阴性，且2年内无生育计划。 7. 有生育能力男性须知情并同意采用有效屏障避孕方法。 8. 自愿参加试验并签署知情同意书。 排除标准： 1. 骨髓和/或中枢神经系统淋巴瘤。 2. 外周血NK细胞比例<5%且培养失败。 3. 合并其他恶性肿瘤。 4. 过去5天内出现与疾病无关的发热。 5. 存在未控制的细菌、真菌、病毒或其他感染。 6. HIV阳性或梅毒螺旋体（TP）阳性。 7. 存在严重心肺、肝肾或脑功能障碍。 8. 存在与方案冲突的其他严重疾病，如自身免疫性疾病、免疫缺陷、严重血小板减少或血小板功能障碍综合征等。 9. 曾接受任何器官移植，包括异基因干细胞移植。 10. 存在严重精神障碍。 11. 无法正常沟通或丧失行为能力，难以评估治疗的安全性和有效性。 12. 妊娠或哺乳期女性。 13. 研究者认为不适合参加本研究。
Inclusion Criteria: 1. Patients with age 15 years to 80 years, with life expectancy greater than 6 months. 2. Pathologically confirmed non-Hodgkin B-cell lymphoma, confirmed by pathological examination at a grade A class 3 hospital or above, with pathology reported less than 3 years ago. 3. First diagnosed relapsed/refractory non-Hodgkin's B-cell lymphoma. 4. ECOG scores were 0 to 2 5. Presence of at least one CT measurable lesion locus with a maximum transverse diameter of ≥1.5 cm before inclusion in the study. 6. For women of childbearing potential, a negative pregnancy test must be confirmed before inclusion in the study and no intention to have children within 2 years. 7. For men of childbearing potential, inform and require the use of an effective barrier contraceptive method. 8. Volunteer to participate in the trial and sign the informed consent form. Exclusion Criteria: 1. Presence of bone marrow or/and central nervous system lymphoma. 2. Patients with less than 5% peripheral blood NK cell percentage and pre-culture failure. 3. Combined with other malignancies. 4. Fever of non-disease-related origin within the last 5 days. 5. Presence of uncontrollable bacterial, fungal, viral or other infections. 6. Patients with HIV, TP positive 7. Patients with severe cardiopulmonary, hepatic and renal, and cerebral dysfunction are present. 8. Presence of other serious diseases that conflict with this protocol, such as autoimmune diseases, immunodeficiencies, severe thrombocytopenia, platelet dysfunction syndrome, etc. 9. Received any form of organ transplantation, including allogeneic stem cell transplantation. 10. Presence of a serious psychiatric disorder. 11. Inability to communicate normally and incapacitation make it difficult to assess the safety and effectiveness of treatment. 12. Pregnant or lactating women. 13. The researchers deemed unsuitable for participation in 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：ORR · Refer to the 2014 version of Lugano standard · up to 5 years of treatment
次要终点：CR；PR；SD；PD；CBR；PFS；DOR；OS
自体NK细胞辅助治疗。
这是一项自体NK细胞辅助治疗复发/难治性非霍奇金B细胞淋巴瘤的单臂研究，研究地点为湖北医药学院襄阳市第一人民医院，计划纳入33例患者。干预方案为R-GemOx联合自体NK细胞，剂量为每平方米体表面积给予（2至4）×10^9个细胞，每14天治疗一次。主要结局指标为客观缓解率（ORR），评估时间包括每个治疗周期，以及治疗后1、3、6、9、12、18、24个月和3年、5年。
This study was a single-arm trial of autologous NK cell adjuvant therapy for relapsed/refractory non-Hodgkin's B-cell lymphoma. The locations isXiangyang No.1 People's Hospital, Hubei University of Medicine. The population was relapsed/refractory non-Hodgkin's B-cell lymphoma. The sample size was 33. The intervention was R-GemOx regimen combined with autologous NK cells. The dose of autologous NK cells was body surface area x (2-4) x 109 cells. The course of treatment was once every 14 days. The primary outcome measure was ORR. The duration of assessment was for each treatment cycle, 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 3 years, and 5 years of treatment.
MEMBER ACCOUNT
登录成功会直接打开下一页。
