ChiCTR2600123238 版本V1.0 版本创建时间2026/04/23 09:07:31 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600123238 

最近更新日期：

Date of Last Refreshed on：

2026-04-23 09:07:25 

注册时间：

Date of Registration：

2026-04-23 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

YMN-C01注射液治疗复发/难治性急性髓系血病的探索性研究

Public title：

An exploratory clinical study of YMN-C01 injection in the treatment of relapsed/refractory acute myeloid leukemia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

YMN-C01注射液治疗复发/难治性急性髓系血病的探索性研究

Scientific title：

An exploratory clinical study of YMN-C01 injection in the treatment of relapsed/refractory acute myeloid leukemia

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：

杨金荣 

研究负责人：

牛挺 

Applicant：

Jinrong Yang 

Study leader：

Ting Niu 

申请注册联系人电话：

Applicant telephone：

+86 135 5034 9291

研究负责人电话：

Study leader's telephone：

+86 189 8060 1242

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：

yangjinrong@wchscu.cn

研究负责人电子邮件：

Study leader's E-mail：

niuting@wchscu.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 Alley, Wuhou District, Chengdu, Sichuan, China

Study leader's address：

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

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：

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/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2026年审(854)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 Research Ethics Committee, West China Hospital of Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-04-21 00:00:00

伦理委员会联系人：

李娜

Contact Name of the ethic committee：

Na Li

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 Alley, Wuhou District, Chengdu, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 28 8542 2023

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 Alley, 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 Alley, Wuhou District, Chengdu, Sichuan, China

经费或物资来源：

四川大学华西医院高峰学科运行经费

Source(s) of funding：

Peak Discipline Operating Fund, West China Hospital, Sichuan University

Target disease：

Acute myeloid leukemia (AML)

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的：评估靶向LILRB3/B4的mRNA治疗性药物（YMN-C01注射液）治疗复发/难治性急性髓系白血病（R/R AML）的安全性和耐受性。 次要目的：评估YMN-C01注射液治疗R/R AML的初步有效性、药代动力学（PK）特征、药效学（PD）特征和免疫原性。  

Objectives of Study：

Primary purpose: To evaluate the safety and tolerability of the LILRB3/B4-targeted mRNA therapeutic drug (YMN-C01 injection) in the treatment of relapsed/refractory acute myeloid leukemia (R/R AML). Secondary purpose: To evaluate the preliminary efficacy, pharmacokinetic (PK) characteristics, pharmacodynamic (PD) characteristics, and immunogenicity of YMN-C01 injection in the treatment of R/R AML.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.自愿签署知情同意书，并遵循方案要求； 2.性别不限； 3.年龄：≥18 岁且≤75岁； 4.预期生存时间≥3 个月； 5.经病理学确诊的符合世界卫生组织（WHO）造血和淋巴组织肿瘤分类 2016（修订版）标准的复发/难治性中高危AML受试者，或对其他药物治疗不耐受（例如治疗期间发生导致永久停药的药物相关的≥3 级毒性）且研究者判断无其他适当治疗的AML 受试者； 6.根据《中国复发难治性急性髓系白血病诊疗指南（2023年版）》，符合复发/难治性急性髓系白血病定义的患者： 1) 复发性AML诊断标准：AML完全缓解（CR）后外周血再次出现白血病细胞或骨髓中原始细胞≥5%（除外巩固化疗后骨髓再生等其他原因）或髓外出现白血病细胞浸润。 2) 难治性AML诊断标准：经过标准方案治疗两个疗程无效的初治病例；CR后经过巩固强化治疗，12个月内复发者；在12个月后复发且经过常规化疗无效者；两次或两次以上复发者；髓外白血病持续存在者。 7.符合以下一项即为复发/难治性 AML 具体包括： 1）经 2 个疗程标准方案治疗无效的初治者； 2） 完全缓解后经过巩固强化治疗，12 个月内复发者； 3）12 个月后复发但经常规化疗无效者； 4） 2 次或多次复发者； 5） 研究者判定无或不适用/不耐受其他治疗的复发或难治性急性髓系白血病患者。 8.形态学评估骨髓中原始细胞需≥5%； 9.骨髓或外周血样本的流式检测结果显示LILRB4和/ 或LILRB3阳性； 10. 体力状况评分 ECOG ≤2 分； 11. 既往抗肿瘤治疗的毒性已恢复至 NCI-CTCAE v5.0 定义的≤1 级（研究者评估可以入组的血细胞计数异常除外；感染参考排除标准；研究者考虑无症状性实验室检查异常除外，如 ALP 升高、高尿酸血症、血清淀粉酶/脂肪酶升高、血糖升高等；研究者判断无安全风险的毒性除外，如脱发、2 级外周 神经毒性、经激素替代治疗稳定的甲状腺功能减退等）； 12. 首次给药前 7 天内器官功能水平符合下列要求，达到以下标准： 1) 肝脏功能：在筛选检查前 7 天内未使用保肝药物纠正的情况下，总胆红素≤1.5 ULN（Gilbert’s 综合征≤3 ULN），转氨酶（AST 和 ALT）≤2.5 ULN，和/或碱性磷酸酶≤5 ULN； 2) 肾脏功能：肌酐（ Cr ）≤ 1.5 ULN 或肌酐清除率（ Ccr ）≥ 50 mL/min （以研究中心的计算标准）； 3) 凝血功能：国际标准化比值（ INR ） ≤1.5 ， 且活化部分凝血活酶时间 （APTT）≤1.5ULN； 4) 尿蛋白≤2+或≤1000mg/24h； 13. 对于绝经前有生育可能的妇女必须在开始治疗之前的 7 天内做妊娠试验，血 清/尿妊娠必须为阴性，必须为非哺乳期；所有入组患者（不管男性或女性） 均应在整个治疗周期及治疗结束后 6 个月采取充分的屏障避孕措施。

Inclusion criteria

1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. No gender limit; 3. Age: >=18 years old and <=75 years old; 4. Expected survival time >=3 months; 5. Subjects with pathologically confirmed relapsed/refractory intermediate-high risk AML according to the World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues 2016 (revision) criteria, Or subjects with AML who are intolerant to other drug therapy (e.g., drug-related grade ≥3 toxicity during treatment leading to permanent discontinuation) and who have no other appropriate treatment as judged by the investigator; 6. According to the Chinese Guidelines for the diagnosis and treatment of relapsed/refractory acute myeloid leukemia (2023 edition), patients who meet the definition of relapsed/refractory acute myeloid leukemia: 1) Relapsed AML was defined as the presence of recurrent leukemia cells in peripheral blood or blasts in bone marrow (≥5%) after complete remission (CR) of AML (except for other reasons such as bone marrow regrowth after consolidation chemotherapy) or extramedullary leukemia cell infiltration. 2) Refractory AML diagnostic criteria: newly diagnosed patients who failed to response to two courses of standard chemotherapy; Patients who relapsed within 12 months after consolidation and intensive therapy; Patients who relapsed after 12 months and failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia. 7. Relapsed/refractory AML is defined as one of the following: 1) newly diagnosed patients who failed to respond to two courses of standard therapy; 2) relapsed within 12 months after consolidation and intensive therapy; 3) relapsed after 12 months but failed to respond to conventional chemotherapy; 4) two or more recurrences; 5) patients with relapsed or refractory acute myeloid leukemia who were not or unsuitable/intolerant to other therapies according to the investigator's judgment. 8. Bone marrow blasts should be >=5%. Flow cytometric analysis of bone marrow or peripheral blood samples positive for LILRB4 and/or LILRB3; 10. ECOG <=2; 11. Toxicity from previous antineoplastic therapy has returned to grade 1 or less, as defined by NCI-CTCAE v5.0 (except for an investigator-assessable blood count abnormality; infection was an exclusion criterion; Investigators considered that asymptomatic laboratory abnormalities, such as elevated alkaline phosphatase, hyperuricemia, elevated serum amylase/lipase, and elevated blood glucose, were excluded. The exception was toxicity that was judged by the investigator to be not a safety risk, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism that was stable with hormone replacement therapy). 12. Within 7 days before the first dose, the level of organ function meets the following requirements and meets the following criteria: 1) liver function: total bilirubin <=1.5 ULN (Gilbert's syndrome ≤3 ULN), transaminases (AST and ALT) <=2.5 ULN, and/or alkaline phosphatase <=5 ULN in the absence of liver-protective medication correction within 7 days before the screening test; 2) renal function: creatinine (Cr) <= 1.5 ULN or creatinine clearance (Ccr) >= 50 mL/min (according to the center's calculation criteria); 3) coagulation function: international normalized ratio (INR) <=1.5 and activated partial thromboplastin time (APTT) <=1.5ULN; 4) proteinuria <=2+ or <=1000mg/24h; 13. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum/urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.

排除标准：

若患者符合以下任一标准，则不能入组： 1. 伴有其它未控的恶性肿瘤； 2. 既往接受过嵌合抗原受体治疗或其他转基因 T 细胞治疗距首次给药不足 6 个月； 3. 急性早幼粒细胞白血病、或 ph+AML、慢性髓系白血病急性变或 MDS（骨髓增生异常综合征）、MPN（骨髓增殖性肿瘤）转化的 AML；或仅接受过二线治疗的低危复发AML者； 4. 在首次给药前 4 周内或 5 个半衰期内（以时间更短的为准）使用过化疗、 生物治疗、免疫治疗、根治性放疗、大手术（研究者定义）、靶向治疗 （包括小分子酪氨酸激酶抑制剂）等抗肿瘤治疗；或首次给药前 2 周内使用姑息性放疗、NMPA 已批准上市用于抗肿瘤治疗的现代中药制剂治疗等； 5. 首次用药前 4 周内接受了重大外科治疗或明显创伤性损伤（不包括穿刺活检、内镜活检等）； 6. 筛选前 6 个月内严重心、脑血管疾病病史，例如：左心室射血分数＜50%、 症状性充血性心力衰竭（CHF）≥2 级（CTCAE v5.0）病史、纽约心脏学会（NYHA）≥2 级的心力衰竭、心肌梗死病史、不稳定型心绞痛、急性冠脉综合征、心梗、脑血管意外、短暂性脑缺血发作（TIA）、脑梗等； 7. QT 间期延长（男性 QTcF＞450 msec 或女性 QTcF＞470 msec）、完全性左束支传导阻滞，III 度房室传导阻滞，频发且不可控的心律失常：如房颤、 房扑、室颤、室扑（一过性房颤、房扑除外）； 8. 活动性自身免疫性疾病和炎性疾病，例如：系统性红斑狼疮、需全身治疗的银屑病、类风湿性关节炎、炎性肠道疾病和桥本氏甲状腺炎等，除外 I 型 糖尿病、仅替代治疗可以控制的甲状腺功能减退、无需全身治疗的皮肤病 （如白癜风、银屑病）； 7. 广泛肠切除病史或存在 Crohn's disease、溃疡性结肠炎或慢性腹泻、肠梗阻； 8. 嗜酸性粒细胞计数高于正常范围，合并严重过敏性疾病或严重过敏反应病史的患者；患有嗜酸性粒细胞相关疾病的患者。 9. 在首次给药前 5 年内诊断为其他恶性肿瘤，以下情况例外：经过根治的皮肤基底细胞癌、皮肤鳞状细胞癌和/或经过根治切除的原位癌； 10. 控制不佳的高血压（收缩压>150 mmHg 或舒张压>100 mmHg）； 11. 根据 CTCAE v5.0 定义为≥3 级的肺部疾病，有需要全身性类固醇治疗的间 质性肺疾病（ILD）史，或现患间质性肺疾病的患者； 12. 存在中枢神经系统侵犯的患者； 13. 存在髓外侵犯的患者; 14. 已知对研究药物及辅料成分过敏者； 15. 既往接受实体器官移植；或3个月内接受过自体干细胞移植。关于异基因造血干细胞移植（allo-HSCT）后复发患者的入排规定：筛选前 6个月内接受过异基因造血干细胞移植的患者排除；筛选时存在急性或慢性移植物抗宿主病（GVHD）的患者排除；对于allo-HSCT后≥6个月、筛选时无活动性GVHD的复发患者，允许入组。 16. 人类免疫缺陷病毒抗体（HIVAb）阳性、活动性结核、活动性乙型肝炎病 毒感染（HBsAg 阳性和/或 HBcAb 阳性且 HBV-DNA 拷贝数＞检测下限） 或活动性丙型肝炎病毒感染（HCV 抗体阳性且 HCV-RNA＞检测下限）； 17. 活动性真菌、细菌或病毒感染（定义为尽管接受适当的抗生素、 抗真菌、 抗病毒治疗和/或其他治疗，但与感染相关的体征/症状仍持续存在，且无改善； 18. 有严重的神经系统或精神疾病病史，包括但不限于：痴呆、抑郁、癫痫发作、双相情感障碍等; 19. 签署知情前 4 周内有临床明显出血或明显出血倾向的受试者，如胃肠道出血、 出血性胃溃疡、血管炎等； 20. 存在有临床症状或需反复引流的胸腹盆腔积液或心包积液； 21. 筛选前 6 个月内需要治疗干预的动脉血栓和肺动脉栓塞等血栓事件；或当前存在需要抗凝治疗的深静脉血栓；输液器相关的血栓形成除外； 22. 首次给药前 4 周或 5 个半衰期（以时间更短的为准）内曾参加另一项临床 试验（以末次给药的时间开始计算）； 23. 妊娠或哺乳女性； 24. 研究者认为不适合采用参加本临床试验的其它情况。

Exclusion criteria：

Patients were not eligible if they met any of the following criteria: 1. Accompanied by other uncontrolled malignant tumors; 2. Prior treatment with chimeric antigen receptor therapy or other transgenic T cells less than 6 months after the first dose; 3. Acute promyelocytic leukemia, or ph+AML, acute transformation of chronic myeloid leukemia or AML transformed from MDS (myelodysplastic syndrome) or MPN (myeloproliferative neoplasm); Or low-risk relapsed AML patients who had received only second-line therapy; 4. Antineoplastic therapy such as chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors) within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Or palliative radiotherapy or modern traditional Chinese medicine preparations approved by NMPA for anti-tumor treatment within 2 weeks before the first dose; 5. Major surgical treatment or obvious traumatic injury (excluding needle biopsy, endoscopic biopsy, etc.) within 4 weeks before the first medication; 6. History of severe cardiovascular or cerebrovascular disease within 6 months before screening, such as: Left ventricular ejection fraction < 50%, history of symptomatic congestive heart failure (CHF) >=grade 2 (CTCAE v5.0), New York Heart Association (NYHA) >= grade 2, history of myocardial infarction, unstable angina pectoris, acute coronary syndrome, myocardial infarction, cerebrovascular accident, transient ischemic attack (TIA), cerebral infarction; 7. Prolonged QT interval (QTcF > 450 msec in male or > 470 msec in female), complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia, such as atrial fibrillation, atrial flutter, ventricular fibrillation, ventricular flutter (except transient atrial fibrillation and atrial flutter); 8. Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases and Hashimoto's thyroiditis, etc., excluding type I diabetes mellitus, hypothyroidism that can be controlled only by replacement therapy, and skin diseases without systemic treatment (such as vitiligo and psoriasis); 7. History of extensive bowel resection or Crohn's disease, ulcerative colitis, chronic diarrhea, intestinal obstruction; 8. Patients with eosinophilia above the normal range and a history of severe allergic diseases or anaphylaxis; Patients with eosinophil-related disorders. 9. Other malignancies diagnosed within 5 years before the first dose, except for radical basal cell carcinoma, squamous cell carcinoma, and/or radical resection carcinoma in situ; 10. Poorly controlled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg); 11. Patients with grade >=3 lung disease according to CTCAE v5.0, a history of interstitial lung disease (ILD) requiring systemic steroid therapy, or current ILD; 12. Patients with central nervous system involvement; 13. Patients with extramedullary invasion; 14. Known to be allergic to the study drugs and excipients; 15. Prior solid organ transplantation; Or had received autologous stem-cell transplantation within 3 months. The inclusion and exclusion criteria for patients with relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT) were as follows: patients who received allo-HSCT within 6 months before screening were excluded; Patients with acute or chronic graft-versus-host disease (GVHD) were excluded. Patients who relapsed more than 6 months after allo-HSCT and without active GVHD at screening were allowed to participate in the study. 16. Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive and/or HBcAb positive and HBV-DNA copy number > the lower limit of detection) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA > the lower limit of detection); 17. Active fungal, bacterial or viral infection (defined as the persistence of signs/symptoms associated with infection without improvement despite the receipt of appropriate antibiotic, antifungal, antiviral and/or other treatments; 18. Have a history of severe neurological or psychiatric disorders, including but not limited to dementia, depression, seizures, bipolar disorder, etc. 19. Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, vasculitis, etc. 20. Presence of pleural, abdominal, pelvic or pericardial effusion with clinical symptoms or requiring repeated drainage; 21. Thrombotic events such as arterial thrombosis and pulmonary embolism requiring therapeutic intervention within 6 months before screening; Or current deep vein thrombosis requiring anticoagulant therapy; Infusion-related thrombosis was excluded. 22. Had participated in another clinical trial within 4 weeks or 5 half-lives, whichever was shorter, before the first dose, calculated from the time of the last dose; 23. Pregnant or lactating women; 24. Other conditions for participation in the trial were not considered appropriate by the investigator.

研究实施时间：

Study execute time：

从 From 2026-05-01 00:00:00至 To 2029-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-01 00:00:00 至 To 2028-04-30 00:00:00  

干预措施：

Interventions：

组别：

低剂量试验组

样本量：

6

Group：

Low dose experimental group

Sample size：

干预措施：

YMN-C01注射液，2 mg/次，静脉输注，D0、D2、D4给药

干预措施代码：

Intervention：

YMN-C01 injection, 2 mg/dose, intravenous infusion on D0, D2, and D4

Intervention code：

组别：

高剂量试验组

样本量：

6

Group：

High dose experimental group

Sample size：

干预措施：

YMN-C01注射液，4 mg/次，静脉输注，D0、D2、D4给药

干预措施代码：

Intervention：

YMN-C01 injection, 4 mg/dose, intravenous infusion on D0, D2, and D4.

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：

三级甲等 

Institution
hospital：

West China Hospital, Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

剂量限制性毒性（DLT）及其发生率

指标类型：

主要指标

Outcome：

Dose-limiting toxicity (DLT) and its incidence rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件（AE）/严重不良事件（SAE）的发生频率和严重程度分级

指标类型：

主要指标

Outcome：

Frequency and severity grading of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

客观缓解率（ORR）

指标类型：

次要指标

Outcome：

Overall Response Rate (ORR) per ELN criteria

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

缓解持续时间（DOR）、无进展生存期（PFS）、总生存期（OS）

指标类型：

次要指标

Outcome：

Pharmacokinetic (PK) parameters (Cmax, Tmax, t1/2, AUC)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

药效学（PD）特征

指标类型：

次要指标

Outcome：

Pharmacodynamic (PD) characteristics (changes in LILRB3/4 positive leukemia cells, CAR expression on T cells)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫原性

指标类型：

次要指标

Outcome：

Immunogenicity (incidence and titers of ADA and Nab)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

外周血

Sample Name：

Blood

Tissue：

Peripheral blood

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

骨髓液

组织：

骨髓

Sample Name：

Bone marrow

Tissue：

Bone marrow

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 75 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）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

试验完成后1年内公开，采用临床试验公共管理平台ResMan向公众开放查询

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The data will be published on the public management platform of clinical trials ResMan within 1 year after the completion of the study.

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：

本课题设计有临床专用CRF表，专人进行纸质记录，并录入电子数据采集和管理系统（如ResMan）。患者临床病史记录为纸质版，主管医师签字后保存于医院病案室，以备查阅。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Each patient is required to fill one CRF table. Data will be recorded on paper CRFs and entered into an Electronic Data Capture (EDC) system like ResMan. Original medical records with signatures of the attending physician will be archived in the hospital's medical records department.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-23 09:07:25