中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600116392
最近更新日期： Date of Last Refreshed on：	2026-01-09 09:47:49
注册时间： Date of Registration：	2026-01-09 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	评价CNK-UT009细胞注射液治疗1型糖尿病患者的安全性、初步有效性、药代动力学的临床研究
Public title：	Clinical study on the safety, preliminary efficacy and pharmacokinetics of CNK-UT009 cell injection in the treatment of type 1 diabetes patients
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评价通用型CNK-UT009细胞注射液治疗1型糖尿病患者的安全性、初步有效性、药代动力学的临床研究
Scientific title：	A clinical study evaluating the safety, preliminary efficacy and pharmacokinetics of the universal CNK-UT009 cell injection in patients with type 1 diabetes.
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	庞晓明	研究负责人：	庞晓明
Applicant：	Pang Xiaoming	Study leader：	Pang Xiaoming
申请注册联系人电话： Applicant telephone：	+86 533 2361126	研究负责人电话： Study leader's telephone：	+86 533 2361126
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	pangxiaoming2022@163.com	研究负责人电子邮件： Study leader's E-mail：	xiaomingpang@yeah.net
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	山东省淄博市张店区共青团西路54号	研究负责人通讯地址：	山东省淄博市张店区共青团西路54号
Applicant address：	No. 54, gongqingtuan West Road, Zhangdian District, Zibo City, Shandong Province	Study leader's address：	No. 54, gongqingtuan West Road, Zhangdian District, Zibo City, Shandong Province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	淄博市中心医院
Applicant's institution：	Zibo Central Hospital
研究负责人所在单位：	淄博市中心医院
Affiliation of the Leader：	Zibo Central Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2024伦审第070号(-3/-4/-1)	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	淄博市中心医院医学伦理专家委员会
Name of the ethic committee：	Zibo central hospital medical ethics expert committee
伦理委员会批准日期： Date of approved by ethic committee：	2024-11-29 00:00:00
伦理委员会联系人：	司志鹏
Contact Name of the ethic committee：	Si ZhiPeng
伦理委员会联系地址：	山东省淄博市张店区共青团西路54号
Contact Address of the ethic committee：	No. 54, gongqingtuan West Road, Zhangdian District, Zibo City, Shandong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 533 2360221	伦理委员会联系人邮箱： Contact email of the ethic committee：	330798149@qq.com

研究实施负责（组长）单位：

淄博市中心医院

Primary sponsor：

Zibo Central Hospital

研究实施负责（组长）单位地址：

山东省淄博市张店区共青团西路54号

Primary sponsor's address：

No. 54, gongqingtuan West Road, Zhangdian District, Zibo City, Shandong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	淄博市中心医院	具体地址：	山东省淄博市张店区共青团西路54号
Institution hospital：	Zibo Central Hospital	Address：	No. 54, gongqingtuan West Road, Zhangdian District, Zibo City, Shandong Province

经费或物资来源：

淄博市中心医院

Source(s) of funding：

Zibo Central Hospital

研究疾病：

1型糖尿病

Target disease：

Type 1 diabetes

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

主要目的：评价 CNK-UT009 细胞注射液治疗 1 型糖尿病患者的安全性和耐受性，确定最大耐受剂量（MTD）次要目的：评价 CNK-UT009 细胞注射液治疗 1 型糖尿病患者的初步有效性评价 CNK-UT009 细胞注射液的药代动力学（PK）特征评价 CNK-UT009 细胞注射液回输后对外周血免疫细胞的影响评价 CNK-UT009 细胞注射液回输后对血清细胞因子的影响评价 CNK-UT009 细胞注射液的免疫原性

Objectives of Study：

Main objective: To evaluate the safety and tolerability of CNK-UT009 cell injection in patients with type 1 diabetes, and to determine the maximum tolerated dose (MTD) Secondary objective: Evaluate the initial effectiveness of CNK-UT009 cell injection in treating patients with type 1 diabetes Evaluate the pharmacokinetic (PK) characteristics of CNK-UT009 cell injection Evaluate the impact of CNK-UT009 cell injection on peripheral blood immune cells after reinfusion Evaluate the effect of CNK-UT009 cell injection on serum cytokines after reinfusion Evaluate the immunogenicity of CNK-UT009 cell injection

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Age: 18 - 65 years old (inclusive of the boundary value), gender not restricted;
2. Diagnosed with autoimmune type 1 diabetes (in accordance with the diagnostic criteria of "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition)"), and after 2-hour mixed meal (MMTT) stimulation during the screening period, the C-peptide peak value was >= 0.2 nmol/L;
3. At least one insulin autoantibody was positive, such as glutamic acid decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (without using insulin or insulin treatment within 2 weeks), zinc transporter protein antibody (ZnT8A);
4. Glycated hemoglobin (HbA1c) >= 6.5% and <= 10.5%;
5. Body mass index (BMI) >= 18 kg/m^2 and <= 35 kg/m^2;
6. Have sufficient organ and bone marrow functions. The laboratory test values within 7 days before enrollment must meet the following requirements, as follows:  Blood routine: Absolute neutrophil count (ANC) >= 1.0 × 10^9/L;
(1).Absolute lymphocyte count (LYC) >= 1.0 × 10^9/L;
(2).Platelet count (PLT) >= 75 × 10^9/L;
(3).Hemoglobin content (HGB) >= 80 g/L;
(4). Heart: Left ventricular ejection fraction (LVEF) >= 50%;
(5).Cardiac function 1-2 grade;
(6). Lung function: Indoor blood oxygen saturation >= 92%;
(7).Liver function: Serum total bilirubin (TBIL) <= 1.5 × ULN;
(8).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 × ULN;
(9). Kidney function: Serum creatinine (Cr) <= 1.5 × ULN;
(10).Glomerular filtration rate (eGFR) .= 60 mL/min/1.73m^2 (calculated by MDRD formula);
7. For pregnant women of childbearing age, the serum or urine pregnancy test results before enrollment must be negative, and they must agree to take acceptable measures to minimize the possibility of pregnancy during the trial;
11.For pregnant women of childbearing age or male patients whose sexual partner is a pregnant woman of childbearing age, effective contraceptive measures must be taken throughout the treatment period and 6 months after the last medication;
8. Agree to abide by the principles and recommendations of "Chinese Guidelines for the Diagnosis and Treatment of Type 1 Diabetes (2021 Edition)" for medical nutrition therapy;
9. Voluntarily participate in the clinical study, understand, be informed of this study, and sign the informed consent form, and be willing to follow all trial procedures.

排除标准：

1) 需要治疗的活动性恶性肿瘤，非黑色素瘤皮肤癌或原位癌（例如乳腺、宫颈）除外； 2) 既往接受器官移植的受试者或准备接受器官移植者； 3) 入组前 4 周内接受过免疫抑制剂治疗和/或研究期间需要长期免疫抑制治疗，允许间歇性使用外用、吸入或鼻内皮质类固醇； 4) 入组前 3 个月内发生任何危及生命的出血事件，包括需要输血治疗、手术或局部治疗、持续药物治疗； 5) 入组前 6 个月内动、静脉血栓栓塞事件，包括心肌梗死、不稳定型心绞痛、脑血管意外或一过性脑缺血发作、肺动脉栓塞、深静脉血栓或其它任何严重血栓栓塞的病史。植入式静脉输液港或导管源性血栓形成，或浅表静脉血栓形成，经过常规抗凝治疗后血栓稳定者除外。允许预防性使用小剂量低分子肝素（如依诺肝素 40 mg/天）； 6) 严重出血倾向或凝血功能障碍，或正在接受溶栓治疗； 7) 不可控制的高血压，经最佳医学治疗后收缩压>160 mmHg 或舒张压>100 mmHg，高血压危象或高血压脑病病史； 8) 症状性充血性心力衰竭（纽约心脏病协会分级 II-IV 级）。症状性或控制不佳的心律失常。先天性长 QT 综合征病史或筛查时校正的 QTc>500 ms（使用 Fridericia 法计算）； 9) 肺纤维化史、间质性肺炎、尘肺、药物相关肺炎、肺功能严重受损等肺部疾病； 10) 活动性肺结核（TB），正在接受抗结核治疗或者首次给药前 1 年内接受过抗结核治疗者；活动性乙型肝炎、丙型肝炎病毒感染者，人免疫缺陷病毒（HIV）感染者，已知的梅毒感染者； 11) 入组前 4 周内有处于活动期或临床控制不佳的严重感染，包括但不限于因感染、菌血症或重度肺炎并发症而住院治疗（轻度泌尿生殖系统感染和上呼吸道感染除外）； 12) 糖尿病并发症，如： a) 酮症酸中毒； b) 肾功能不全（尿蛋白≥2+，eGFR<60mL/min/1.73m2）； c) 活动期或未治疗的增生性视网膜病变； d) 糖尿病足溃疡； e) 糖尿病导致的截肢； f) 严重的周围神经病变。 13) 入组前 4 周或者 5 个半衰期（药物）内接受过任何非胰岛素降糖药物、影响糖代谢的药物，以时间较短者为准； 14) 入组前 6 个月内发生 2 次或以上严重、无法解释的低血糖事件； 15) 无法完成混合餐耐量试验（MMTT），或 MMTT 试验的混合餐中任何成分产生明显过敏（如过敏性休克）的病史； 16) 入组前 4 周内接受过其它临床研究的治疗； 17) 入组前 4 周内接受过减毒活疫苗者； 18) 既往使用过任何基因治疗产品者； 19) 已知对于 CNK-UT009 细胞注射液的任何成分过敏； 20) 患有已知精神疾病或药物滥用疾病，且这些疾病可能会干扰受试者配合研究要求的能力； 21) 研究者认为有潜在或对本研究评估有干扰的其他危及生命严重并发症的受试者； 22) 研究者认为的不适合参加该研究的其他情况；

Exclusion criteria：

1. Active malignant tumors that require treatment, excluding non-melanoma skin cancer or carcinoma in situ (such as breast and cervical cancer); 2. Subjects who have previously undergone organ transplantation or are preparing for organ transplantation; 3. Subjects who received immunosuppressive therapy within 4 weeks prior to enrollment and/or require long-term immunosuppressive treatment during the study, allowing intermittent use of topical, inhaled or nasal corticosteroids; 4. Subjects who experienced any life-threatening bleeding event within 3 months prior to enrollment, including those requiring blood transfusion treatment, surgery or local treatment, and continuous medication; 5. Subjects who had any thromboembolic events in the arteries and veins within 6 months prior to enrollment, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis or any other serious thromboembolic disease. Implanted venous infusion ports or catheter-related thrombosis, or superficial venous thrombosis, with stable thrombus after conventional anticoagulation treatment, are excluded. Permissive use of low-dose low-molecular-weight heparin (such as enoxaparin 40 mg/day) for prophylaxis; 6. Severe bleeding tendency or coagulation dysfunction, or undergoing thrombolytic therapy; 7. Uncontrolled hypertension, with systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg after optimal medical treatment, or history of hypertensive crisis or hypertensive encephalopathy; 8. Symptomatic congestive heart failure (New York Heart Association grade II-IV); 1.symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected QTc >500 ms (calculated using the Fridericia method); 9. History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired pulmonary function, etc. 10. Active pulmonary tuberculosis (TB), subjects who are currently undergoing anti-TB treatment or have received anti-TB treatment within 1 year before the first administration; 2.active hepatitis B or C virus infections, human immunodeficiency virus (HIV) infections, known syphilis infections; 11. Subjects who had active or poorly controlled severe infections within 4 weeks prior to enrollment, including but not limited to those hospitalized due to infection, bacteremia or severe pneumonia complications (excluding mild urinary and respiratory tract infections); 12. Diabetic complications, such as: (1) ketoacidosis; (2) renal insufficiency (urine protein >=2+, eGFR <60 mL/min/1.73m^2); (3) active or untreated proliferative retinopathy; (4) diabetic foot ulcers; (5) amputation due to diabetes; (6). severe peripheral neuropathy; 13. Subjects who had active or poorly controlled severe infections within 4 weeks prior to enrollment, including but not limited to those hospitalized due to infection, bacteremia or severe pneumonia complications (excluding mild urinary and respiratory tract infections); 14. Subjects who had 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment; 15. Unable to complete the mixed meal tolerance test (MMTT), or history of any significant allergy (such as anaphylactic shock) to any component of the mixed meal in the MMTT test; 16. Subjects who had received treatment in other clinical studies within 4 weeks prior to enrollment; 17. Subjects who had received attenuated live vaccines within 4 weeks prior to enrollment; 18. Subjects who had used any gene therapy products previously; 19. Known to be allergic to any component of the CNK-UT009 cell injection solution; 20. Having known mental disorders or drug abuse disorders, and these disorders may interfere with the subject's ability to comply with the requirements of the study; 21. Subjects who have other life-threatening serious complications that may affect the assessment of this study; 22. Other circumstances that the researchers consider unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2024-11-27 00:00:00至 To 2026-11-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-04-01 00:00:00 至 To 2026-11-10 00:00:00

干预措施：

Interventions：

组别：	低剂量组/中剂量组/高剂量组	样本量：	18
Group：	Low-dose group / Medium-dose group / High-dose group	Sample size：	18
干预措施：	细胞注射液	干预措施代码：
Intervention：	Insulin and hypoglycemic drugs	Intervention code：

组别：	剂量扩展阶段	样本量：	5
Group：	Dose expansion group	Sample size：	5
干预措施：	细胞注射液	干预措施代码：
Intervention：	Insulin and hypoglycemic drugs	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	淄博市中心医院	单位级别：	三级甲等
Institution hospital：	Zibo Central Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	药代动力学评价	指标类型：	次要指标
Outcome：	Pharmacokinetic evaluation	Type：	Secondary indicator
测量时间点：	剂量递增阶段采集时间点：第 1 周期回输期的首日回输前 1h±30min、末日回输完成后 1h±10min，DLT 观察期的 D1±2h、D3±2h、D7±1d、D14±2d、D21±2d；第 2~4	测量方法：	每个时间点采集 1ml 抗凝全血，送中心实验室检测。PK 血样应尽量根据研究计划采集，但是 PK 样本采集时间点也可能根据给药频率的调整进行调整，后续受试者的 PK 样本采集时间可能根据前期得到的临床 PK 数据结果进行调整。另外，患者发生 SAE 或退出研究当天，应尽可能立即采集计划外的 PK 血样。
Measure time point of outcome：	Before the first day of reinfusion 1h±30min	Measure method：	At each time point, 1 ml of anticoagulated whole blood is collected and sent to the central laboratory for testing. The PK blood samples should be collected as per the research plan as much as possible. However, the collection time points of the PK samples may also be adjusted according to the adjustment of the administration frequency. The collection time of the PK samples for subsequent subjects may be adjusted based on the clinical PK data obtained previously. Additionally, on the day when a

指标中文名：	持续葡萄糖检测	指标类型：	主要指标
Outcome：	CGM	Type：	Primary indicator
测量时间点：	在进食前 10 分钟（-10）、摄入时(0)以及进食后 30、 60、90 和 120 分钟采集血糖和 C 肽样本。	测量方法：	通过葡萄糖传感器监测皮下组织间液的葡萄糖浓度
Measure time point of outcome：	Blood glucose and C-peptide samples were collected 10 minutes before eating (-10), during eating (0)	Measure method：	Monitor the glucose concentration in the interstitial fluid of the subcutaneous tissue through a glucose sensor

指标中文名：	外周血免疫细胞亚群评价	指标类型：	次要指标
Outcome：	Evaluation of peripheral blood immune cell subsets	Type：	Secondary indicator
测量时间点：	剂量递增阶段采集时间点：筛选期；第 1 周期观察期的 D21±2d；第 2~4 周期观察期的 D14±2d；治疗随访期每3个月±7d（M3/6/9/12）以及退出研究时进行样本采集。剂量扩展阶段	测量方法：	每个时间点采集 1ml 促凝全血，送中心实验室检测。
Measure time point of outcome：	D21±2d；D14±2d；	Measure method：	At each time point, 1 ml of activated whole blood was collected and sent to the central laboratory for testing.

指标中文名：	混合餐耐量试验	指标类型：	主要指标
Outcome：	MMTT	Type：	Primary indicator
测量时间点：	在进食前 10 分钟（-10）、摄入时(0)以及进食后 30、 60、90 和 120 分钟采集血糖和 C 肽样本。	测量方法：	采集血糖和 C 肽样本
Measure time point of outcome：	Blood glucose and C-peptide samples were collected 10 minutes before eating (-10), at the time of in	Measure method：	Collect blood glucose and C-peptide samples

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	65	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	文章发表后，经研究者同意后可邮箱获取；
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the article is published, it can be obtained by email with the consent of the researcher;
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	纸质材料归档保存于GCP资料室
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The paper materials are archived and stored in the GCP archive room.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-01-09 09:46:30