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：	ChiCTR2600123875
最近更新日期： Date of Last Refreshed on：	2026-04-30 15:15:33
注册时间： Date of Registration：	2026-04-30 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	YMN-V112用于类风湿关节炎治疗的安全性和有效性研究
Public title：	Safety and Efficacy of YMN-V112 in the Treatment of Rheumatoid Arthritis
注册题目简写：
English Acronym：
研究课题的正式科学名称：	YMN-V112用于类风湿关节炎治疗的安全性和有效性研究
Scientific title：	Safety and Efficacy of YMN-V112 in the Treatment of Rheumatoid Arthritis
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：	林楠	研究负责人：	马学磊
Applicant：	Nan Lin	Study leader：	Xuelei Ma
申请注册联系人电话： Applicant telephone：	+86 28 8542 2683	研究负责人电话： Study leader's telephone：	+86 28 8542 2683
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：	linnan@stu.scu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	linnan@stu.scu.edu.cn
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：	中国四川省成都市武侯区国学巷37号	研究负责人通讯地址：	中国四川省成都市武侯区国学巷37号
Applicant address：	37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China	Study leader's address：	37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China
申请注册联系人邮政编码： Applicant postcode：	067513	研究负责人邮政编码： Study leader's postcode：	067513
申请人所在单位：	四川大学华西医院
Applicant's institution：	West China Hospital, Sichuan University
研究负责人所在单位：	四川大学华西医院
Affiliation of the Leader：	West China Hospital, Sichuan University

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：	2026年审(860)号	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：	四川大学华西医院生物医学伦理审查委员会
Name of the ethic committee：	Biomedical Ethics Committee of West China Hospital, Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-22 00:00:00
伦理委员会联系人：	邓绍林
Contact Name of the ethic committee：	Shaolin Deng
伦理委员会联系地址：	中国四川省成都市武侯区国学巷37号
Contact Address of the ethic committee：	37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 28 8542 2654	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

West China Hospital, Sichuan University

研究实施负责（组长）单位地址：

中国四川省成都市武侯区国学巷37号

Primary sponsor's address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	四川	市(区县)：	成都
Country：	China	Province：	Sichuan	City：	Chengdu
单位(医院)：	四川大学华西医院	具体地址：	中国四川省成都市武侯区国学巷37号
Institution hospital：	West China Hospital, Sichuan University	Address：	37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

经费或物资来源：

SCI经费

Source(s) of funding：

SCI funding

研究疾病：

类风湿关节炎

Target disease：

Rheumatoid arthritis

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：

队列研究

Study design：

Cohort study

研究目的：

1. 主要目的：探索YMN-V112在治疗类风湿关节炎中的安全性 2. 次要目的：探索YMN-V112治疗类风湿关节炎的最佳剂量探索YMN-V112治疗类风湿关节炎的有效性探索YMN-V112治疗类风湿关节炎中相关生物标记物

Objectives of Study：

Primary Objective: To investigate the safety of YMN-V112 in the treatment of rheumatoid arthritis (RA).Secondary Objectives:To explore the optimal dosage of YMN-V112 for the treatment of RATo evaluate the efficacy of YMN-V112 in the treatment of RATo investigate the relevant biomarkers associated with YMN-V112 treatment in RA

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) Subjects who have signed the written informed consent form (ICF) and are able to complete the study in full compliance with the study protocol.
(2) Aged between 18 and 65 years, of either sex.
(3) Body weight >= 30 kg.
 (4) Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA, with a disease duration of >= 6 months.
 (5) Swollen Joint Count (SJC) >= 6 (based on the 66-joint count) and Tender Joint Count (TJC) >= 6 (based on the 68-joint count) at the screening period; if a joint presents with both swelling and tenderness, it shall be included in both SJC and TJC (excluding prosthetic joints).
(6) C-reactive protein (CRP) >= 5 mg/L, or erythrocyte sedimentation rate (ESR) > 28 mm/hr at the screening period.
(7) At screening, if the subject is receiving prednisone or an equivalent dose of other corticosteroids, the subject must have been maintained on a stable dose for at least 4 weeks prior to the first dose of study drug, with a prednisone or equivalent dose <= 10 mg/day.
(8) For women of childbearing potential (WOCBP): negative serum pregnancy test at screening; the subject or their spouse must use appropriate and effective contraceptive measures (e.g., abstinence, oral contraceptives, intrauterine device (IUD), dual barrier method (e.g., condom plus contraceptive diaphragm)) throughout the study period; must be non-pregnant and non-lactating.
(9) Have received at least one conventional synthetic disease-modifying anti-rheumatic drug (csDMARD); concomitant use of background medications including methotrexate (MTX), leflunomide, hydroxychloroquine, sulfasalazine, Tripterygium wilfordii preparations, iguratimod is allowed; no washout is required for patients on a long-term stable dose of these agents.
(10) Disease Activity Score 28 (DAS28) >= 3.2.
(11) Subjects with inadequate response to biological agents including tumor necrosis factor-alpha (TNF-α) inhibitors, interleukin-6 (IL-6) inhibitors, Janus kinase (JAK) inhibitors, and anti-CD20 monoclonal antibodies: enrollment is allowed only after a washout period of 5 half-lives of the respective agent, whichever is longer.
(12) Subjects with mild fluctuation of disease activity during the screening or washout period may receive paracetamol (acetaminophen) for symptomatic management.

排除标准：

（1）既往接受过红细胞膜制剂治疗，对其中任何成份过敏者；（2） ACR功能分级为IV级或长期卧床/久坐轮椅者；（3）既往病史或现病史中有类风湿关节炎以外的炎性关节疾病者（例如痛风、反应性关节炎、银屑病关节炎、脊柱关节炎、莱姆病等）；或其他系统性自身免疫性疾病者（例如系统性红斑狼疮、硬皮病、炎性肌病、混合性结缔组织病或其他重叠综合征，但类风湿关节炎继发舍格伦综合征患者除外）；（4）存在研究者认为有临床意义的严重的控制不佳的伴随疾病者，例如（但不限于）神经系统、心血管、肾、肝、内分泌或胃肠道疾病；（5）患有任何可能影响本试验疗效评估（特别是关节疼痛和肿胀）的先天性或获得性神经系统疾病、血管疾病或系统性疾病者（例如帕金森病、脑瘫、糖尿病性神经病变）；或患有可能干扰疼痛评价的神经病变或其他疼痛性病症者；（6）在筛选访视前或筛选期间内进行的检查显示恶性肿瘤、肺部感染者；结核筛查结果阳性且经研究者判断为活动性结核病者，对于判断为潜伏性结核者，在试验首次给药前未接受感染科医生意见预防性治疗或治疗不足4 周者；（7）在首次给药前4周内接受过关节内皮质类固醇治疗者；（8）筛选前1个月或原试验药物5个半衰期（以时间较长者为准）内参加过其他药物临床研究；（9）筛选检查符合以下任一条件者：血清肌酐>1.5倍正常值上限；ALT或AST>1.5倍正常值上限；PLT<100x10^9/L；WBC<3.5x10^9/L；ANC<1.5x10^9/L；总胆红素>1.5倍正常值上限；纤维蛋白原低于正常值下限（参考各中心值）；（10）筛选期存在活动性静脉血栓者，或既往有深静脉血栓/肺栓塞病史且经研究者判断仍属于高静脉血栓风险者；（11）研究者认定的其他情况；

Exclusion criteria：

(1) Subjects with previous treatment with erythrocyte membrane preparations or allergy to any component thereof. (2) Subjects with ACR functional class IV, or long-term bedridden/wheelchair-bound status. (3) Subjects with a past or current history of inflammatory joint diseases other than rheumatoid arthritis (e.g., gout, reactive arthritis, psoriatic arthritis, spondyloarthritis, Lyme disease, etc.); or other systemic autoimmune diseases (e.g., systemic lupus erythematosus, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndromes), excluding patients with Sjögren’s syndrome secondary to rheumatoid arthritis. (4) Subjects with clinically significant, severe and uncontrolled concomitant diseases judged by the investigator, including but not limited to neurological, cardiovascular, renal, hepatic, endocrine or gastrointestinal disorders. (5) Subjects with any congenital or acquired neurological diseases, vascular diseases or systemic diseases that may interfere with efficacy evaluation of the study treatment (especially joint pain and swelling), such as Parkinson’s disease, cerebral palsy, diabetic neuropathy; or those with neuropathy or other painful conditions that may confound pain assessment. (6) Subjects with confirmed malignant tumors or pulmonary infection identified by examinations at or prior to the screening visit; subjects with positive tuberculosis screening results and diagnosed as active tuberculosis by the investigator; subjects with latent tuberculosis who have not received prophylactic treatment per infectious disease specialist advice or have completed less than 4 weeks of treatment before the first study drug administration. (7) Subjects who have received intra-articular corticosteroid therapy within 4 weeks prior to the first dosing. (8) Participation in another interventional clinical trial within 1 month before screening or within 5 half-lives of the investigational product, whichever is longer. (9) Subjects meeting any of the following laboratory abnormalities at screening:Serum creatinine > 1.5 times the upper limit of normal (ULN);ALT or AST > 1.5 × ULN;Platelet (PLT) < 100×10^9/L;White blood cell (WBC) < 3.5×10^9/L;Absolute neutrophil count (ANC) < 1.5×10^9/L;Total bilirubin > 1.5 × ULN;Fibrinogen below the lower limit of normal (refer to local laboratory reference ranges). (10) Subjects with active venous thrombosis at screening, or a medical history of deep vein thrombosis/pulmonary embolism deemed to carry a high venous thromboembolism risk by the investigator. (11) Any other conditions deemed ineligible by the investigator.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2028-05-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2028-05-01 00:00:00

干预措施：

Interventions：

组别：	治疗组	样本量：	9
Group：	Treatment group	Sample size：	9
干预措施：	YMN-V112, 本研究按照 3+3 原则进行剂量递增。采取固定剂量给药，分为低，中，高三个剂量组。药物注射方式为静脉注射，每周一次，总共注射4次。每次给药后应至少现场观察 120 min，	干预措施代码：
Intervention：	YMN-V112. This study adopts a 3+3 design for dose escalation. Fixed-dose administration will be applied, with divided into three dose groups: low, medium and high, respectively. The study drug is administered via intravenous injection once weekly for a total of 4 injections. After each dosing, on-site medical observation shall be conducted for no less than 120 minutes.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川	市(区县)：	成都
Country：	China	Province：	Sichuan	City：	Chengdu
单位(医院)：	四川大学华西医院	单位级别：	三甲
Institution hospital：	West China Hospital, Sichuan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	安全性	指标类型：	主要指标
Outcome：	Safety	Type：	Primary indicator
测量时间点：	治疗期间及随访时	测量方法：	患者主观反馈及客观检验结果, 参照CTCAE V5.0
Measure time point of outcome：	During treatment and at follow-up	Measure method：	Subjective feedback and objective test results of patients are referred to CTCAE V5.0

指标中文名：	初步有效性	指标类型：	次要指标
Outcome：	Preliminary effectiveness	Type：	Secondary indicator
测量时间点：	基线至各随访时点	测量方法：	DAS28、HAQ、VAS、关节肿胀及压痛计数、SDAI、CDAI、ESR、CRP 的变化
Measure time point of outcome：	Baseline to each follow-up time point	Measure method：	Changes in DAS28, HAQ, VAS, joint swelling and tenderness counts, SDAI, CDAI, ESR, CRP

指标中文名：	探索性终点	指标类型：	次要指标
Outcome：	Exploratory endpoint	Type：	Secondary indicator
测量时间点：	基线至各随访时点	测量方法：	IL-6、TNF-α、类风湿因子、CCP、免疫球蛋白等生物标志物的动态变化及其与临床疗效、安全性指标之间的相关性
Measure time point of outcome：	Baseline to each follow-up time point	Measure method：	The dynamic changes of biomarkers such as IL-6, TNF-α, rheumatoid factor, CCP, and immunoglobulin and their correlation with clinical efficacy and safety indicators

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：

尚未开始

Not yet 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:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	本研究的数据采集和管理由病例报告表/电子病例报告表（Case Record Form/electronic Case Record Form，CRF/eCRF）和电子数据采集系统（Electronic Data Capture，EDC）两部分组成。研究开始前，应完成 CRF/eCRF、数据管理计划、统计分析计划、数据录入与核查流程、质疑处理流程、数据更正规则、数据库锁定流程及资料归档要求的制定和确认。本研究所有数据均应来源于可核查的原始记录，包括但不限于知情同意记录、筛查记录、人口学资料、既往史、肿瘤病史、既往抗肿瘤治疗史、合并疾病及合并用药、体格检查、ECOG 评分、生命体征、实验室检查结果、影像学检查结果、给药记录、不良事件和严重不良事件、免疫原性检测结果、载体脱落检测结果、随访记录、停药或退出研究记录等。研究者或经授权的研究人员应及时、准确、完整、规范地将相关数据录入 CRF/eCRF，不得事后集中补记。 EDC 系统用于研究数据的电子化录入、保存、审核、质疑、修改、导出和数据库锁定。系统访问权限应实行分级授权和最小必要权限原则，仅限经授权的研究者、研究护士、数据管理员、监查员、稽查员、伦理委员会及监管部门人员在各自职责范围内访问相关数据。受试者资料应采用唯一受试者识别代码进行去标识化管理，姓名、身份证号、联系方式等可直接识别个人身份的信息应与研究数据库分开保存，以保护受试者隐私和个人信息安全。数据管理过程中，应对 CRF/eCRF 数据进行完整性、准确性、逻辑一致性、范围合理性、访视时间窗及与原始资料一致性的核查。对于缺失、矛盾、异常或不符合方案要求的数据，数据管理员或监查人员应及时发出数据质疑，研究现场应在规定时限内完成核实、回复和必要更正。所有数据更正均应保留原始记录、修改后内容、修改日期、修改人员及修改原因，确保数据全过程可追溯。数据库锁定前，应完成全部预设数据核查、关键质疑关闭、主要方案偏离评估、关键终点评审、分析数据集确认及统计程序复核。数据库锁定后，如确需解锁修改数据，应履行书面审批程序，并记录解锁原因、涉及范围、修改内容、再次锁定时间及其对统计分析结果的可能影响。研究结束后，应按照预设统计分析计划完成安全性、耐受性、免疫原性及初步有效性分析，并形成研究总结报告。所有 CRF/eCRF 数据、原始资料、质疑记录、审计追踪记录、样本台账、药物管理记录及其他研究相关文件均应按照 GCP 和研究机构要求妥善保存和归档。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and management in this study will consist of two components: the Case Record Form/electronic Case Record Form (CRF/eCRF) and the Electronic Data Capture (EDC) system. Before study initiation, the CRF/eCRF, data management plan, statistical analysis plan, data entry and verification procedures, query management procedures, data correction rules, database locking procedures, and document archiving requirements will be developed and confirmed. All study data shall be derived from verifiable source documents, including but not limited to informed consent records, screening records, demographic information, medical history, tumor history, prior anti-tumor treatment history, concomitant diseases and concomitant medications, physical examination findings, ECOG performance status, vital signs, laboratory test results, imaging results, dosing records, adverse events and serious adverse events, immunogenicity results, vector shedding results, follow-up records, and records of treatment discontinuation or study withdrawal. The investigator or authorized study personnel shall enter relevant data into the CRF/eCRF in a timely, accurate, complete, and standardized manner. Retrospective batch entry without contemporaneous source documentation shall be avoided. The EDC system will be used for electronic data entry, storage, review, query management, modification, export, and database locking. Access to the EDC system shall be role-based and follow the principle of minimum necessary access. Only authorized investigators, study nurses, data managers, monitors, auditors, ethics committee members, and regulatory authorities may access relevant data within the scope of their responsibilities. Subject data will be de-identified using a unique subject identification code. Direct personal identifiers, such as name, identification number, and contact information, shall be stored separately from the study database to protect subject privacy and personal information security. During data management, CRF/eCRF data will be checked for completeness, accuracy, logical consistency, reasonable range, visit-window compliance, and consistency with source documents. For missing, inconsistent, abnormal, or protocol-noncompliant data, data queries shall be issued by the data manager or monitor in a timely manner, and the study site shall verify, respond to, and correct the data within the required timeframe. All data corrections shall retain the original record, corrected content, date of correction, person making the correction, and reason for correction, so that the entire data trail remains traceable and auditable. Before database lock, all predefined data checks, closure of key queries, assessment of major protocol deviations, review of key endpoints, confirmation of analysis datasets, and validation of statistical programs shall be completed. After database lock, if database unlocking and data modification are necessary, written approval shall be obtained, and the reason for unlocking, scope involved, content of modification, time of re-locking, and potential impact on statistical analysis results shall be documented. After study completion, analyses of safety, tolerability, immunogenicity, and preliminary efficacy will be performed according to the predefined statistical analysis plan, and a clinical study report will be prepared. All CRF/eCRF data, source documents, query records, audit trail records, sample logs, investigational product management records, and other study-related documents shall be properly retained and archived in accordance with GCP and institutional requirements.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-04-30 15:15:27