注册号：
Registration number：
ChiCTR2600120807 最近更新日期：
Date of Last Refreshed on：
2026-03-19 17:43:04 注册时间：
Date of Registration：
2026-03-19 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
基于mRNA-LNP递送三特异性抗体在自身免疫病中的探索性临床研究Public title：
An Exploratory Clinical Study of mRNA-LNP Delivered Trispecific Antibodies in Autoimmune Diseases注册题目简写：English Acronym：研究课题的正式科学名称：
基于mRNA-LNP递送三特异性抗体在自身免疫病中的探索性临床研究Scientific title：
An Exploratory Clinical Study of mRNA-LNP Delivered Trispecific Antibodies in Autoimmune Diseases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：
冯凤兰
研究负责人：
付迪/李谨 Applicant：
Fenglan Feng
Study leader：
Di Fu/ Jin Li 申请注册联系人电话：
Applicant telephone：
+86 137 6066 6090
研究负责人电话：
Study leader's telephone：
+86 137 6066 6090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：
phoenix.feng@gzlab.ac.cn
研究负责人电子邮件：
Study leader's E-mail：
jl@gzlab.ac.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：
广东省广州市越秀区东风西路195号
研究负责人通讯地址：
广东广州是荔湾区桥中中路28号Applicant address：
195 West Dongfeng Road, Yuexiu District, Guangzhou City, Guangdong Province, China
Study leader's address：
28 Qiaozhong Middle Road, Liwan District, Guangzhou City, Guangdong Province, 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：
广州医科大学附属第一医院Applicant's institution：
The First Affiliated Hospital of Guangzhou Medical University研究负责人所在单位：
广州医科大学附属第一医院Affiliation of the Leader：
The First Affiliated Hospital of Guangzhou Medical 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：
ES-2026-024-01/ES-2026-024-02
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：
广州医科大学附属第一医院科研项目审查伦理委员会Name of the ethic committee：
The Ethics Committee for Scientific Research Projects of The First Affiliated Hospital of Guangzhou Medical University伦理委员会批准日期：
Date of approved by ethic committee：
2026-03-05 00:00:00伦理委员会联系人：
刘远捷Contact Name of the ethic committee：
Yuanjie Liu伦理委员会联系地址：
广东广州是荔湾区桥中中路28号Contact Address of the ethic committee：
28 Qiaozhong Middle Road, Liwan District, Guangzhou City, Guangdong Province, China伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 20 8156 6445
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：
广州医科大学附属第一医院Primary sponsor：
The First Affiliated Hospital of Guangzhou Medical University研究实施负责（组长）单位地址：
广东广州是荔湾区桥中中路28号Primary sponsor's address：
28 Qiaozhong Middle Road, Liwan District, Guangzhou City, Guangdong Province, 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)：
广东省
市(区县)：
广州市
Country：
China
Province：
Guangdong
City：
Guangzhou
单位(医院)：
广州医科大学附属第一医院
具体地址：
广东广州是荔湾区桥中中路28号
Institution
hospital：
The First Affiliated Hospital of Guangzhou Medical University
Address：
28 Qiaozhong Middle Road, Liwan District, Guangzhou City, Guangdong Province, China经费或物资来源：
自筹Source(s) of funding：
Self-funding研究疾病：
难治性神经系统性红斑狼疮（SLE）、系统性硬化症（SSc）、ANCA相关血管炎（AAV）、特发性炎性肌病（IIM）、干燥综合征（SS）、多发性硬化（MS）、视神经脊髓炎谱系疾病（NMOSD）、重症肌无力（MG）、毒性弥漫性甲状腺肿（Graves）、自免性脑炎（AE）、自身免疫性溶血性贫血（AIHA）和免疫性血小板减少性紫癜（ITP）等自身免疫性疾病患者 Target disease：
patients with refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE) with neurological involvement, Systemic Sclerosis (SSc), ANCA-associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), Myasthenia Gravis (MG), Graves' disease, Autoimmune Encephalitis (AE), Autoimmune Hemolytic Anemia (AIHA), and Immune Thrombocytopenia (ITP).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：
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：评价脂质递送三靶点药物体系治疗自身免疫性疾病的安全性和耐受性。
次要目的：评价脂质递送三靶点药物体系治疗自身免疫性疾病的有效性；
评估脂质递送三靶点药物体系的免疫原性；
评估患者生活质量的变化。
探索性目的：
评价脂质递送三靶点药物体系在体内清除外周血B细胞和浆细胞的能力；
评价脂质递送三靶点药物体系治疗后B细胞亚群的变化。 Objectives of Study：
Primary Objective:
To evaluate the safety and tolerability of a lipid-based trispecific drug delivery system (e.g., mRNA-LNP) in the treatment of autoimmune diseases.
Secondary Objectives:
To evaluate the efficacy of the lipid-based trispecific drug delivery system in treating autoimmune diseases;
To assess the immunogenicity of the lipid-based trispecific drug delivery system;
To evaluate changes in patients' quality of life.
Exploratory Objectives:
To assess the capacity of the lipid-based trispecific drug delivery system to deplete peripheral B cells and plasma cells in vivo;
To evaluate changes in B-cell subsets following treatment with the lipid-based trispecific drug delivery system.药物成份或治疗方案详述：
Description for medicine or protocol of treatment in
detail：
纳入标准：
入选病例均须根据以下标准选择：
入选标准:
患者必须符合所有入选标准方可被认为有资格参与本研究：
所有患者的通用入选标准：
1.受试者自愿参加本试验，并签署知情同意书。
2.年龄≥18岁且≤70岁，性别不限。
3.器官功能和实验室检查：
a)肝功能：丙氨酸氨基转移酶（ALT）和天冬氨酸氨基转移酶（AST）≤3×正常上限（ULN），总胆红素（TBIL）≤2×ULN（Gilbert综合征除外）。
b)肾功能：肌酐≤1.5×ULN或肌酐清除率≥40 ml/min。
c)血常规：中性粒细胞计数≥1×10^9/L、血红蛋白≥60g/L、血小板计数≥20×10^9/L、淋巴细胞计数>0.3×10^9/L。
d)凝血功能：国际标准化比值（INR）≤ 1.5×ULN，或凝血酶原时间（PT）≤ 1.5×ULN。
e)静息状态下在室内空气时的血氧饱和度（SpO2）≥92%。
f)超声心动图显示左室射血分数（LVEF）≥50%。
4.筛选时具有生育能力的女性受试者血清或尿妊娠试验检测结果呈阴性。
5.经过常规药物治疗无效，或者常规药物治疗出现严重副作用的患者。
SLE患者入选标准：
1.根据2019年欧洲抗风湿病联盟（EULAR）/美国风湿病学会（ACR）分类标准或2012年系统性红斑狼疮国际临床协作组（SLICC）标准确诊为SLE。
2.筛选前需接受过糖皮质激素联合免疫抑制剂和/或生物制剂治疗至少2个月，且剂量稳定>2周，疾病仍处于活动状态（即，既往接受糖皮质激素+免疫抑制剂或糖皮质激素+免疫抑制剂+生物制剂，任何以上药物单药应用不符合）。口服皮质类固醇必须满足如下要求：1）泼尼松（或等效药物）≥7.5mg/天；2）当与免疫抑制剂和/或生物制剂联合使用时，皮质类固醇无每日最小剂量要求。
3.筛选时抗核抗体（ANA）阳性，和/或抗ds-DNA抗体阳性，和/或抗Smith抗体阳性。
4.筛选期SLEDAI-2K评分>6分，且“临床”SLEDAI-2K评分≥4分。
注：“临床”SLEDAI-2K是SLEDAI-2K评分中不包括可归因于任何尿液或实验室检查结果（包括免疫学指标）的评分：
·包括以下临床项目评分：关节炎、肌炎、皮疹、脱发、黏膜溃疡、胸膜炎、心包炎或血管炎；
·排除归因于发热、SLE头痛和器质性脑综合征的评分。
狼疮性肾炎患者筛选期若存在尿蛋白>0.5g/24h或UPCR>500mg/g；或活动性尿沉渣（排除感染情况下尿红细胞>5个/高倍视野或尿白细胞>5个/高倍视野，或红细胞管型，或白细胞管型），可无需满足“临床”SLEDAI-2K评分≥4分。
5.筛选时医师总体评估（PGA）评分≥1.0分（0~3分视觉模拟量表VAS）。
SSc患者入选标准：
1.根据2013年ACR/EULAR分类标准诊断为SSc。
2.筛选时诊断为弥漫性皮肤型SSc。
3.有活动性疾病的证据，定义为至少有以下一项：
a)在筛选前2年内新发SSc
b)在筛选前6个月内两个新的身体区域出现新的皮肤受累或恶化（mRSS评估定义的17个身体区域）
c)在筛选前6个月内胸部或腹部出现新的身体区域受累或恶化
d)在筛选前6个月内出现皮肤增厚恶化（mRSS≥2分）
e)在筛选前3个月内和筛选时，病例中至少记录有1起肌腱摩擦感
f)在筛选时进行肺功能检查与筛选前12个月内进行的既往肺功能比较，确定FVC绝对降幅≥5%预测值或DLCO绝对降幅≥10%预测值，且呼吸道症状恶化
g)在筛选时进行HRCT与筛选前12个月内进行的既往HRCT比较，结果显示间质性肺病（ILD）进展
4.筛选时用力肺活量（FVC）≥50%，一氧化碳弥散量（DLCO）≥45%预测值。
5.常规治疗无效或疾病缓解后复发。常规治疗定义为：使用糖皮质激素（泼尼松>0.5mg/kg/d或等效剂量）和环磷酰胺，及以下任何一种免疫调节药物：抗疟药、硫唑嘌呤、吗替麦考酚酯、甲氨蝶呤、来氟米特、他克莫司、环孢素，和/或生物制剂如利妥昔单抗、贝利尤单抗等，治疗累计时间>6个月。
AAV患者入选标准：
1.符合2022 ACR/EULAR制定的ANCA相关血管炎的诊断标准，包括显微镜下多血管炎（MPA）、肉芽肿性多血管炎（GPA）和嗜酸性肉芽肿性多血管炎（EGPA）。
2.既往或筛选期检测ANCA相关抗体阳性（特异性抗髓过氧化物酶抗体，MPO-ANCA阳性或抗蛋白酶3抗体，PR3-ANCA阳性）。
3.伯明翰血管炎活动度量表（BVAS）评分满足至少有1个主要条目，或至少3个次要条目，或至少2个肾脏条目；
4.既往标准治疗（SOC）失败，定义为以下任一情况：
a)经至少4个月的糖皮质激素和环磷酰胺或利妥昔单抗治疗后未能实现缓解；
b)既往获得缓解后疾病复发
c)既往接受至少6个月的SOC治疗，包括：糖皮质激素、环磷酰胺、硫唑嘌呤、吗替麦考酚酯、甲氨蝶呤、来氟米特、他克莫司、环孢素以及生物制剂（如利妥昔单抗、美泊利单抗、avacopan），但仍有活动性疾病。
IIM患者入选标准：
1.根据2017年ACR/EULAR分类标准诊断为IIM（包括拟诊或确诊，即概率≥55%），分型包括皮肌炎（DM）、抗合成酶综合征（ASS）及免疫介导的坏死性肌病（IMNM）。
2.处于活动期患者，即以下六项核心指标中至少2项异常者：肌力下降（MMT-8<142），医师总体评估（PhGA，10cm VAS）≥2cm，患者总体评估（PtGA，10cm VAS）≥2cm，肌外疾病活动整体评分（采用MDAAT评分工具对肌肉外疾病活动评分）≥2cm，健康评估问卷（HAQ）≥0.25，CK肌酶水平≥1.5×ULN。
3.既往或筛选期检测肌炎特异性自身抗体（抗ARS抗体，抗Jo-1抗体，抗HA/YRS抗体，抗Zo抗体，抗EJ抗体，抗PL-7抗体，抗OJ抗体，抗KS抗体，抗PL-12抗体，抗Mi-2抗体，抗TIF1抗体，抗MDA5抗体，抗SAE抗体，抗NXP2抗体，抗SRP抗体，抗HMGCR抗体）阳性。
4.常规治疗无效或疾病缓解后复发。常规治疗定义为：使用糖皮质激素（泼尼松>1 mg/kg/d或等效剂量）和/或至少1种免疫调节药物：如抗疟药、硫唑嘌呤、吗替麦考酚酯、环磷酰胺、甲氨蝶呤、他克莫司、环孢素，和/或生物制剂：如利妥昔单抗和贝利尤单抗。
SS患者入选标准：
1.根据2016年ACR/EULAR分类标准诊断为原发性SS。
2.既往或筛选期检测抗SSA/Ro抗体阳性。
3.筛选时欧洲抗风湿病联盟制定的干燥综合征疾病活动指数（ESSDAI）≥6分。
4.常规治疗无效或疾病缓解后复发。常规治疗定义为：使用糖皮质激素（泼尼松>1 mg/kg/d或等效剂量）和/或至少1种免疫调节药物：如抗疟药、硫唑嘌呤、吗替麦考酚酯、环磷酰胺、甲氨蝶呤、他克莫司、环孢素，和/或生物制剂：如利妥昔单抗和贝利尤单抗，治疗时间累计至少6个月。
MS患者入选标准：
1.根据2017年修订的McDonald标准诊断为复发型多发性硬化（RMS），包括临床孤立综合征、复发缓解型MS（RRMS）和活动性继发进展型MS。
2.扩展残疾状态评分（EDSS）≤6.0。
3.筛选前1年内至少有1次复发记录，或筛选前2年内至少有2次复发记录，或在筛选前1年内脑部有活动性钆增强病灶。
4.筛选前神经系统症状稳定≥30天。
MG患者入选标准：
1.诊断为全身型重症肌无力的患者。
2.美国重症肌无力基金会（MGFA）临床分型II型、III型或IV型。
3.筛选时血清学检测乙酰胆碱受体抗体（AChR-Ab）或肌肉特异性受体酪氨酸肌酶抗体（MuSK-Ab）或低密度脂蛋白受体相关蛋白抗体（LRP4-Ab）阳性，或既往病历记录AChR-Ab、MuSK-Ab或LRP4-Ab阳性。
4.重症肌无力日常活动评价量表（MG-ADL）≥6分，且眼部相关评分小于总分的50%。
5.重症肌无力定量评分（QMG）≥8分，且≥4个项目评分至少2分以上。
6.根据研究者的判断，对MG当前稳定治疗的疗效不佳，稳定的治疗定义：a）如果正在服用乙酰胆碱酯酶抑制剂，受试者必须在筛选前已接受稳定的剂量和方案治疗至少2周；b）如果正在使用糖皮质激素，受试者必须在筛选前已接受稳定的剂量和方案治疗至少4周；c）如果受试者正在接受免疫抑制剂治疗，受试者必须在筛选前接受免疫抑制剂治疗≥6个月，并接受稳定剂量治疗≥3个月。允许的免疫抑制剂为硫唑嘌呤、吗替麦考酚酯、甲氨蝶呤、环孢素、他克莫司、环磷酰胺等。或因不耐受或缺乏疗效在筛选前停用皮质类固醇和/或免疫抑制剂至少4周。
NMOSD患者入选标准：
1.符合2015年国际NMO诊断小组（IPND）制定的NMOSD诊断标准。
2.筛选期水通道蛋白4免疫球蛋白G（AQP4-IgG）阳性或既往病历记录AQP4-IgG阳性。
3.筛选前2年内至少经历过2次有临床记录的复发，或筛选前1年内至少经历过1次有临床记录的复发。
4.至少有一种免疫抑制剂已使用超过一年，但症状仍然难以控制。
5.扩展残疾状态评分（EDSS）≤7.5。
6.筛选前患者接受稳定的治疗（如有），稳定治疗的定义如下：a）免疫抑制剂：筛选前患者接受免疫抑制药物（如硫唑嘌呤、环磷酰胺、吗替麦考酚酯、他克莫司、甲氨蝶呤等）剂量稳定至少8周；b）糖皮质激素：筛选前剂量稳定至少4周；c）患者如果接受静脉免疫球蛋白输注或血浆置换治疗，最后一次治疗结束需在筛选前4周以上。
毒性弥漫性甲状腺肿（Graves）入选标准：
受试者需为难治性Graves病患者，定义为符合以下任一条件：
1.连续接受标准抗甲状腺药物治疗 ≥ 3 年，仍无法停药；
2.接受 ≥ 2 次放射性碘治疗后仍需药物控制甲亢（最后一次放射性碘治疗需在至少 6 个月前）；
3.在符合停药标准后停药，且复发次数 ≥ 2 次。
4.血清 TRAb（TSH受体抗体）水平 ≥ 正常范围上限的 3 倍（≥ 5 IU/L）
5.外周血 B 细胞 CD19 表达阳性（流式细胞术检测结果）。
6.愿意参与本临床研究、签署知情同意书，并能良好遵循治疗及随访计划。 （停药标准定义为：连续抗甲状腺药物治疗 ≥ 18 个月，并且维持甲状腺功能正常 ≥ 6 个月，同时 TRAb 和 TSI（甲状腺刺激免疫球蛋白）均为阴性。复发定义为在符合停药标准并停药后，甲亢再次发生，同时 TRAb/TSI 阳性。）
自免性脑炎（AE）入选标准：
1.符合自身免疫性脑炎诊断标准（如抗NMDA受体抗体阳性、典型临床表现及影像/脑脊液支持）。
2.经免疫治疗（至少包括激素+IVIG±利妥昔单抗）后仍持续或反复发作（如6个月以上未缓解）。
3.持续神经系统损害（如精神行为异常、癫痫、自主神经功能障碍）或神经功能评分（如改良Rankin评分≥3分）。
自身免疫性溶血性贫血（AIHA）入选标准：
1.确诊AIHA：符合典型AIHA诊断标准（血红蛋白下降、网织红细胞升高、Coombs试验阳性等）。明确分型（温抗体型或冷抗体型），且排除药物、感染、肿瘤等继发因素。
2.难治性/复发性疾病：传统治疗失败，至少两种标准疗法（如糖皮质激素+利妥昔单抗、免疫抑制剂）无效或无法耐受。脾切除术后仍复发（适用于温抗体型）。
3.持续严重溶血：血红蛋白<8 g/dL，依赖输血维持，或反复出现危及生命的溶血危象。
免疫性血小板减少性紫癜（ITP）入选标准：
1.确诊ITP：符合国际公认诊断标准（血小板计数持续<100×10^9/L，排除其他血小板减少原因，如药物、感染、恶性肿瘤等）。分型明确（原发或继发），继发性ITP需控制基础疾病（如SLE、抗磷脂综合征）。
2.难治性/复发性疾病：标准治疗失败，至少两种一线治疗（如糖皮质激素+静脉丙种球蛋白/TPO受体激动剂）无效或依赖大剂量药物维持。利妥昔单抗治疗无效或复发（适用成人患者）。脾切除术后仍复发（适用于脾切除候选者）。
3.高风险出血倾向：血小板持续<30×10^9/L伴活动性出血（如黏膜出血、血尿）或出血高风险（如高龄、高血压）。Inclusion criteria
Enrolled cases must be selected according to the following criteria:
Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be considered eligible for participation in this study.
General Inclusion Criteria for All Patients:
1. The subject voluntarily participates in this trial and signs the informed consent form.
2. Age >= 18 years and <= 70 years, male or female.
3. Organ function and laboratory tests:
a) Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 × upper limit of normal (ULN), total bilirubin (TBIL) <= 2 × ULN (except for Gilbert's syndrome).
b) Renal function: Creatinine <= 1.5 × ULN or creatinine clearance ≥ 40 ml/min.
c) Hematology: Neutrophil count >= 1 × 10⁹/L, hemoglobin ≥ 60 g/L, platelet count >= 20 × 10⁹/L, lymphocyte count > 0.3 × 10⁹/L.
d) Coagulation function: International normalized ratio (INR) <= 1.5 × ULN, or prothrombin time (PT) <= 1.5 × ULN.
e) Oxygen saturation (SpO₂) >= 92% on room air at rest.
f) Left ventricular ejection fraction (LVEF) >= 50% as shown by echocardiography.
4.Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening.
5.Patients who have failed to respond to conventional drug therapy or who have experienced severe side effects from conventional drug therapy.
Inclusion Criteria for Patients with SLE:
1. Diagnosis of SLE according to the 2019 EULAR/ACR classification criteria or the 2012 SLICC criteria.
2. Must have received treatment with glucocorticoids combined with immunosuppressants and/or biologics for at least 2 months prior to screening, with a stable dose for > 2 weeks, and the disease is still active (i.e., prior treatment with glucocorticoids + immunosuppressants or glucocorticoids + immunosuppressants + biologics; monotherapy with any of these agents does not qualify). Oral corticosteroids must meet the following requirements: 1) Prednisone (or equivalent) >= 7.5 mg/day; 2) When used in combination with immunosuppressants and/or biologics, there is no daily minimum dose requirement for corticosteroids.
3. Positive for antinuclear antibody (ANA), and/or positive for anti-dsDNA antibody, and/or positive for anti-Smith antibody at screening.
4. SEDAI-2K score > 6 and "clinical" SLEDAI-2K score >= 4 at screening.
Note: "Clinical" SLEDAI-2K is the SLEDAI-2K score excluding scores attributable to any urinary or laboratory findings (including immunological parameters):
.Includes scores for the following clinical items: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, or vasculitis.
.Excludes scores attributable to fever, SLE headache, and organic brain syndrome.
For patients with lupus nephritis, if there is urine protein > 0.5 g/24h or UPCR > 500 mg/g, or active urinary sediment (urine RBC > 5/HPF or urine WBC > 5/HPF, or RBC casts, or WBC casts, after excluding infection) at screening, the requirement for a "clinical" SLEDAI-2K score >= 4 may not need to be met.
5. Physician's Global Assessment (PGA) score >= 1.0 at screening (0-3 Visual Analogue Scale, VAS).
Inclusion Criteria for Patients with SSc:
1. Diagnosis of SSc according to the 2013 ACR/EULAR classification criteria.
2. Diagnosis of diffuse cutaneous SSc at screening.
3. Evidence of active disease, defined as at least one of the following:
a) New onset of SSc within 2 years prior to screening.
b) New skin involvement or worsening in two new body areas (of the 17 body areas defined by mRSS assessment) within 6 months prior to screening.
c) New involvement or worsening in a new body area of the chest or abdomen within 6 months prior to screening.
d) Worsening of skin thickening (mRSS >= 2 points) within 6 months prior to screening.
e) At least one instance of tendon friction rub documented in the case history within 3 months prior to screening and at screening.
f) Absolute decline in FVC of ≥ 5% predicted or absolute decline in DLCO of >= 10% predicted on pulmonary function tests at screening compared to previous pulmonary function tests performed within 12 months prior to screening, accompanied by worsening respiratory symptoms.
g) Progression of interstitial lung disease (ILD) on HRCT at screening compared to previous HRCT performed within 12 months prior to screening.
4.Forced vital capacity (FVC) >= 50% predicted and diffusing capacity for carbon monoxide (DLCO) >= 45% predicted at screening.
5. Failure of conventional therapy or relapse after disease remission. Conventional therapy is defined as: treatment with glucocorticoids (prednisone > 0.5 mg/kg/d or equivalent) and cyclophosphamide, and any of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and/or biologics such as rituximab, belimumab, etc., for a cumulative duration > 6 months.
Inclusion Criteria for Patients with AAV:
1. Meets the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).
2. Positive for ANCA-associated antibodies (specific anti-myeloperoxidase antibodies, MPO-ANCA positive, or anti-proteinase 3 antibodies, PR3-ANCA positive) in the past or at screening.
3. Birmingham Vasculitis Activity Score (BVAS) meets the criteria of at least 1 major item, or at least 3 minor items, or at least 2 renal items.
4. Failure of prior standard of care (SOC) therapy, defined as any of the following:
a) Failure to achieve remission after at least 4 months of treatment with glucocorticoids and cyclophosphamide or rituximab.
b) Disease relapse after previously achieving remission.
c) Received at least 6 months of prior SOC therapy, including: glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics (e.g., rituximab, mepolizumab, avacopan), but still has active disease.
Inclusion Criteria for Patients with IIM:
1. Diagnosis of IIM according to the 2017 ACR/EULAR classification criteria (including probable or definite, i.e., probability >= 55%), including subtypes such as dermatomyositis (DM), antisynthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).
2. Patients in the active phase, defined as abnormality in at least 2 of the following six core set measures: muscle strength deficit (MMT-8 < 142), Physician Global Assessment (PhGA, 10 cm VAS) >= 2 cm, Patient Global Assessment (PtGA, 10 cm VAS) >= 2 cm, global assessment of extra-muscular disease activity (scored using the MDAAT tool for extra-muscular disease activity) >= 2 cm, Health Assessment Questionnaire (HAQ) >= 0.25, CK muscle enzyme level >= 1.5 × ULN.
3. Positive for myositis-specific autoantibodies (anti-ARS antibodies, anti-Jo-1 antibody, anti-HA/YRS antibody, anti-Zo antibody, anti-EJ antibody, anti-PL-7 antibody, anti-OJ antibody, anti-KS antibody, anti-PL-12 antibody, anti-Mi-2 antibody, anti-TIF1 antibody, anti-MDA5 antibody, anti-SAE antibody, anti-NXP2 antibody, anti-SRP antibody, anti-HMGCR antibody) in the past or at screening.
4. Failure of conventional therapy or relapse after disease remission. Conventional therapy is defined as: use of glucocorticoids (prednisone > 1 mg/kg/d or equivalent) and/or at least one immunomodulatory drug: such as antimalarials, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, tacrolimus, cyclosporine, and/or biologics: such as rituximab and belimumab.
Inclusion Criteria for Patients with SS:
1. Diagnosis of primary Sjögren's syndrome according to the 2016 ACR/EULAR classification criteria.
2. Positive for anti-SSA/Ro antibody in the past or at screening.
3. EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score >= 6 at screening.
4. Failure of conventional therapy or relapse after disease remission. Conventional therapy is defined as: use of glucocorticoids (prednisone > 1 mg/kg/d or equivalent) and/or at least one immunomodulatory drug: such as antimalarials, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, tacrolimus, cyclosporine, and/or biologics: such as rituximab and belimumab, for a cumulative treatment duration of at least 6 months.
Inclusion Criteria for Patients with MS:
1. Diagnosis of relapsing forms of multiple sclerosis (RMS) according to the 2017 revised McDonald criteria, including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS.
2. Expanded Disability Status Scale (EDSS) score <= 6.0.
3. At least one documented relapse within 1 year prior to screening, or at least two documented relapses within 2 years prior to screening, or active gadolinium-enhancing lesions in the brain within 1 year prior to screening.
4. Neurological symptoms stable for ≥ 30 days prior to screening.
Inclusion Criteria for Patients with MG:
1. Patients diagnosed with generalized myasthenia gravis.
2. Myasthenia Gravis Foundation of America (MGFA) clinical classification Type II, III, or IV.
3. Positive for acetylcholine receptor antibodies (AChR-Ab), muscle-specific receptor tyrosine kinase antibodies (MuSK-Ab), or low-density lipoprotein receptor-related protein 4 antibodies (LRP4-Ab) by serological testing at screening, or documented history of AChR-Ab, MuSK-Ab, or LRP4-Ab positivity in medical records.
4. Myasthenia Gravis Activities of Daily Living (MG-ADL) score >= 6, with ocular domain score less than 50% of the total score.
5. Quantitative Myasthenia Gravis (QMG) score >= 8, with at least 4 items scoring at least 2 points each.
6. As judged by the investigator, has a suboptimal response to current stable MG therapy. Stable therapy is defined as: a) If taking acetylcholinesterase inhibitors, the subject must have been on a stable dose and regimen for at least 2 weeks prior to screening; b) If using glucocorticoids, the subject must have been on a stable dose and regimen for at least 4 weeks prior to screening; c) If the subject is receiving immunosuppressive therapy, the subject must have been on immunosuppressive therapy for >= 6 months and on a stable dose for >= 3 months prior to screening. Permitted immunosuppressants are azathioprine, mycophenolate mofetil, methotrexate, cyclosporine, tacrolimus, cyclophosphamide, etc. Or, has discontinued corticosteroids and/or immunosuppressants due to intolerance or lack of efficacy at least 4 weeks prior to screening.
Inclusion Criteria for Patients with NMOSD:
1. Meets the 2015 NMOSD diagnostic criteria established by the International Panel for NMO Diagnosis (IPND).
2. Positive for aquaporin-4 immunoglobulin G (AQP4-IgG) at screening or documented history of AQP4-IgG positivity in medical records.
3. Experienced at least 2 clinically documented relapses within 2 years prior to screening, or at least 1 clinically documented relapse within 1 year prior to screening.
4. Has been on at least one immunosuppressant for more than one year but symptoms remain difficult to control.
5. Expanded Disability Status Scale (EDSS) score <= 7.5.
6. Patients receiving stable treatment prior to screening (if any), stable treatment defined as: a) Immunosuppressants: Patients receiving a stable dose of immunosuppressive drugs (e.g., azathioprine, cyclophosphamide, mycophenolate mofetil, tacrolimus, methotrexate, etc.) for at least 8 weeks prior to screening; b) Glucocorticoids: Stable dose for at least 4 weeks prior to screening; c) If a patient has received intravenous immunoglobulin infusions or plasma exchange, the last treatment must have been completed at least 4 weeks prior to screening.
Inclusion Criteria for Graves' Disease:
Subjects must be patients with refractory Graves' disease, defined as meeting any of the following conditions:
1. Continuous treatment with standard anti-thyroid drugs for >= 3 years but still unable to discontinue medication.
2. Requires medication to control hyperthyroidism after receiving >= 2 radioactive iodine treatments (last radioactive iodine treatment must be at least 6 months prior).
3. Relapse occurred >= 2 times after discontinuing medication upon meeting discontinuation criteria.
4. Serum TRAb (TSH receptor antibody) level >= 3 times the upper limit of the normal range (>= 5 IU/L).
5. Positive CD19 expression on peripheral blood B cells (as detected by flow cytometry).
6. Willing to participate in this clinical study, sign the informed consent form, and adhere well to the treatment and follow-up plan.
(Discontinuation criteria are defined as: continuous anti-thyroid drug therapy for >= 18 months, and maintaining normal thyroid function for >= 6 months, with both TRAb and TSI (thyroid-stimulating immunoglobulin) negative. Relapse is defined as the recurrence of hyperthyroidism along with positive TRAb/TSI after discontinuing medication upon meeting discontinuation criteria.)
Inclusion Criteria for Autoimmune Encephalitis (AE):
1. Meets the diagnostic criteria for autoimmune encephalitis (e.g., positive anti-NMDA receptor antibodies, typical clinical manifestations, and imaging/cerebrospinal fluid support).
2. Persistent or recurrent episodes after immunotherapy (including at least corticosteroids + IVIG +/- rituximab) (e.g., no remission after more than 6 months).
3. Persistent neurological deficits (e.g., psychiatric/behavioral abnormalities, seizures, autonomic dysfunction) or neurological function score (e.g., modified Rankin Score >= 3 points).
Inclusion Criteria for Autoimmune Hemolytic Anemia (AIHA):
1. Confirmed diagnosis of AIHA: Meets the typical diagnostic criteria for AIHA (decreased hemoglobin, elevated reticulocytes, positive Coombs test, etc.). Specific type (warm antibody or cold antibody) is identified, and secondary factors such as drugs, infection, tumors are excluded.
2. Refractory/Relapsed disease: Failure of conventional therapy, defined as ineffective or intolerant to at least two standard therapies (e.g., glucocorticoids + rituximab, immunosuppressants). Recurrence after splenectomy (applicable for warm antibody type).
3. Persistent severe hemolysis: Hemoglobin < 8 g/dL, dependent on blood transfusions for maintenance, or recurrent life-threatening hemolytic crises.
Inclusion Criteria for Immune Thrombocytopenia (ITP):
1. Confirmed diagnosis of ITP: Meets internationally accepted diagnostic criteria (persistent platelet count < 100 × 10⁹/L, excluding other causes of thrombocytopenia such as drugs, infection, malignancy). Type (primary or secondary) is specified; for secondary ITP, the underlying disease (e.g., SLE, antiphospholipid syndrome) should be controlled.
2. Refractory/Relapsed disease: Failure of standard therapy, defined as ineffective or dependent on high-dose maintenance with at least two first-line treatments (e.g., glucocorticoids + intravenous immunoglobulin/TPO receptor agonists). Ineffective or relapsed after rituximab therapy (applicable for adult patients). Recurrence after splenectomy (applicable for splenectomy candidates).
3. High-risk bleeding tendency: Persistent platelet count < 30 × 10⁹/L accompanied by active bleeding (e.g., mucosal bleeding, hematuria) or high bleeding risk (e.g., advanced age, hypertension).排除标准：
排除标准
如果符合以下任一排除标准，则患者将不被允许入组本研究：
排除标准：
1.研究者确定的存在安全性风险或问题的任何具有临床意义的基础疾病，难治性神经系统性红斑狼疮（SLE）、系统性硬化症（SSc）、ANCA相关血管炎（AAV）、特发性炎性肌病（IIM）、干燥综合征（SS）、多发性硬化（MS）、视神经脊髓炎谱系疾病（NMOSD）、重症肌无力（MG）、毒性弥漫性甲状腺肿（Graves）、自免性脑炎（AE）、自身免疫性溶血性贫血（AIHA）和免疫性血小板减少性紫癜（ITP）等除外。
2.非SLE/LN、AAV/AAGN、SSc和IIM相关的急进性肾小球肾炎，定义为自诊断以来3个月内eGFR降低≥50%。
3.筛选前曾患有疾病非直接相关的其他仍未控制的严重情况，如严重溶血性贫血、严重血小板减少性紫癜、严重粒细胞缺乏症、严重心肌损害、严重肺炎或肺出血、严重肝炎、严重血管炎，活动性中枢神经系统症状包括脑血管意外、动脉瘤、癫痫、抽搐/惊厥、失语症、中风、重度脑损伤、痴呆、帕金森病、小脑疾病、脑器质性综合征或精神病等。
4.筛选前合并非狼疮导致的具有临床意义的中枢神经系统疾病或病理改变，包括但不限于：脑血管意外、动脉瘤、癫痫、抽搐/惊厥、失语症、中风、重度脑损伤、痴呆、帕金森病、小脑疾病、脑器质综合征或精神病。
5.SLE/LN受试者：a) 严重活动性中枢神经系统（CNS）狼疮，包括精神病、癫痫发作、狼疮性头痛或与神经精神狼疮相关的其他体征或症状，由有资质的专科医生在筛选期评估确定。b)药物性狼疮或继发性狼疮。
6.AAV/AAGN受试者：a) 药物性或继发性AAV/AAGN。b) 筛选时存在需要有创肺通气支持的肺泡出血。
7.MG受试者：筛选前2周存在未控制的重症肌无力危象。
8.IIM受试者：筛选时存在重度横纹肌溶解或CK水平≥120×ULN。
9.SSc受试者：a) 筛选前1年内存在硬皮病肾危象。b) 筛选前6个月内存在心包填塞。c) 筛选前3个月内存在指端溃疡活动性感染。d) 筛选时存在指端坏疽。
10.有同种异体骨髓或干细胞移植或实体器官移植史（如肾、肺、心脏移植）或未来计划进行此类移植。
11.既往有自体或同种异体CAR T治疗史。
12.有显著心血管功能障碍病史或当前存在显著心血管功能障碍，包括：a)在筛选前12个月内，存在纽约心脏病协会（NYHA）心功能分级为≥III级的充血性心力衰竭体征或症状；b)超声心动图显示左心室射血分数（LVEF）<50%（筛选期评估）；c) 筛选前6个月内有心肌梗死、不稳定型心绞痛、未控制的或有症状的房性心律失常、任何室性心律失常或其他有显著临床意义的心脏病。d) 肺动脉高压，包括继发性肺动脉高压，WHO功能分级为>2级。
13.重度哮喘或慢性阻塞性肺疾病（COPD）。与医学监查员讨论后，可考虑接受稳定治疗的轻度或中度哮喘或COPD。
14.胸部CT有晚期纤维化间质性肺疾病证据，并且最新肺功能检查显示用力肺活量(FVC) 450 msec（毫秒），女性QTcF>470 msec，根据单次ECG或间隔超过3分钟的三次重复ECG中平均QTcF（按Fridericia公式校正的QT间期）值。
17.签署ICF前3年内罹患恶性肿瘤。以下情况除外：经根治性治疗的非黑素瘤皮肤癌、局部前列腺癌、活检证实的宫颈原位癌或宫颈涂片检出的鳞状上皮内病变、淋巴瘤、甲状腺乳头状癌，以及已完全切除的乳腺原位癌。
18.妊娠或哺乳期女性，或计划在研究期间和脂质递送三靶点药物体系输注完成后6个月内怀孕的女性受试者。
19.有显著慢性活动性或复发性感染病史或体征，或筛选时实验室检查结果显示为需要抗生素、抗病毒药物或抗真菌药治疗的显著慢性活动性或复发性感染。
20.筛选时存在未受控制的感染。如果为单纯性尿路感染（UTI）和单纯性细菌性咽炎对积极治疗有反应，且经研究者与医学监查员同意后，允许纳入。
21.筛选期HBsAg、HCV RNA或HIV检测呈阳性。如果受试者HBsAg呈阴性但HBcAb呈阳性，应进行乙型肝炎病毒DNA检测，如果乙型肝炎病毒DNA检测呈阳性，则该受试者应从研究中排除。
22.在入组前<4周内接种过减毒活疫苗，或计划在研究过程中接种减毒活疫苗。
23.接受过以下任何一种治疗：a)入组前72小时内使用过治疗剂量的皮质类固醇（定义为泼尼松或等效物＞20mg/天）。b) 入组前4周内使用任何其他相关的临床研究药物。但研究治疗期间无效或疾病进展，并且在入组前已至少经过5个半衰期则允许入组。
24.筛选前30天内有≥2级出血病史，或需要长期持续使用抗凝药物（如华法林、低分子肝素或Xa因子抑制剂等）治疗。
25.正在接受肾脏替代治疗或预期在研究期间需要接受肾脏替代治疗。
26.入组前1年内有药物或酒精滥用史。
27.对研究药物或研究治疗的任何成分或制剂（如DMSO）有超敏反应或危及生命的反应史。
28.研究者认为可能影响研究参与、对受试者构成安全性风险或可能混淆研究结果解读的任何情况。Exclusion criteria：
Patients will not be eligible for enrollment in this study if they meet any of the following exclusion criteria:
Exclusion Criteria:
1. Any clinically significant underlying medical condition that, in the investigator's judgment, poses a safety risk or concern, excluding refractory Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), ANCA-associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies (IIM), Sjögren's Syndrome (SS), Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorders (NMOSD), Myasthenia Gravis (MG), Graves' disease, Autoimmune Encephalitis (AE), Autoimmune Hemolytic Anemia (AIHA), and Immune Thrombocytopenia (ITP).
2. Rapidly progressive glomerulonephritis not directly related to SLE/LN, AAV/AAGN, SSc, or IIM, defined as a ≥ 50% reduction in eGFR within 3 months since diagnosis.
3. Presence of other uncontrolled severe conditions not directly related to the primary disease prior to screening, such as severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe pneumonia or pulmonary hemorrhage, severe hepatitis, severe vasculitis, or active central nervous system symptoms including cerebrovascular accident, aneurysm, epilepsy, seizures/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis, etc.
4. Presence of clinically significant central nervous system disease or pathological changes not attributable to lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
5. For SLE/LN subjects: a) Severe active central nervous system (CNS) lupus, including psychosis, seizures, lupus headache, or other signs or symptoms associated with neuropsychiatric lupus, as determined by a qualified specialist physician during the screening period. b) Drug-induced lupus or secondary lupus.
6. For AAV/AAGN subjects: a) Drug-induced or secondary AAV/AAGN. b) Presence of alveolar hemorrhage requiring invasive ventilatory support at screening.
7. For MG subjects: Presence of uncontrolled myasthenic crisis within 2 weeks prior to screening.
8. For IIM subjects: Presence of severe rhabdomyolysis or CK level >= 120 × ULN at screening.
9. For SSc subjects: a) Presence of scleroderma renal crisis within 1 year prior to screening. b) Presence of cardiac tamponade within 6 months prior to screening. c) Presence of active infection of digital ulcers within 3 months prior to screening. d) Presence of digital gangrene at screening.
10. History of allogeneic bone marrow or stem cell transplantation or solid organ transplantation (e.g., kidney, lung, heart transplant) or planned future such transplantation.
11. Prior history of autologous or allogeneic CAR T-cell therapy.
12. History or current presence of significant cardiovascular dysfunction, including: a) Signs or symptoms of congestive heart failure corresponding to New York Heart Association (NYHA) class >= III within 12 months prior to screening; b) Left ventricular ejection fraction (LVEF) < 50% as shown by echocardiography (assessed at screening); c) Myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmia, or other clinically significant heart disease within 6 months prior to screening; d) Pulmonary hypertension, including secondary pulmonary hypertension, with WHO functional class > 2.
13. Severe asthma or chronic obstructive pulmonary disease (COPD). Mild or moderate asthma or COPD on stable treatment may be considered after discussion with the Medical Monitor.
14. Evidence of advanced fibrotic interstitial lung disease on chest CT, and the most recent pulmonary function tests showing forced vital capacity (FVC) < 40% predicted or diffusing capacity for carbon monoxide (DLCO) < 30% predicted.
15. Presence of significant pulmonary or cardiac manifestations (e.g., pericarditis, pleural effusion) at screening that, in the investigator's assessment, might affect subject safety or the ability to tolerate CAR T-cell therapy.
16. QTcF > 450 msec for males, QTcF > 470 msec for females, based on the average QTcF (QT interval corrected by Fridericia's formula) value from a single ECG or three repeated ECGs taken more than 3 minutes apart.
17. Malignancy within 3 years prior to signing the ICF. The following exceptions apply: non-melanoma skin cancer treated with curative intent, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesion detected on cervical smear, lymphoma, papillary thyroid cancer, and breast carcinoma in situ that has been completely resected.
18. Pregnant or lactating females, or female subjects planning to become pregnant during the study and within 6 months after completion of the lipid-based trispecific drug delivery system infusion.
19. History or signs of significant chronic active or recurrent infection, or laboratory findings at screening indicating a significant chronic active or recurrent infection requiring antibiotics, antivirals, or antifungals.
20. Presence of uncontrolled infection at screening. Subjects with uncomplicated urinary tract infection (UTI) and uncomplicated bacterial pharyngitis responding to active treatment may be allowed for inclusion after agreement between the investigator and the Medical Monitor.
21. Positive test for HBsAg, HCV RNA, or HIV at screening. If a subject is negative for HBsAg but positive for HBcAb, hepatitis B virus DNA testing should be performed; if hepatitis B virus DNA test is positive, the subject should be excluded from the study.
22. Receipt of a live attenuated vaccine < 4 weeks prior to enrollment, or planned receipt of a live attenuated vaccine during the study period.
23. Receipt of any of the following treatments: a) Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent > 20 mg/day) within 72 hours prior to enrollment. b) Use of any other relevant investigational drug within 4 weeks prior to enrollment. However, subjects who had no response or disease progression during previous investigational treatment and have undergone at least 5 half-lives prior to enrollment may be allowed.
24. History of bleeding events >= Grade 2 within 30 days prior to screening, or requiring long-term continuous use of anticoagulant medications (e.g., warfarin, low molecular weight heparin, or factor Xa inhibitors, etc.).
25. Currently receiving renal replacement therapy or anticipated to require renal replacement therapy during the study period.
26. History of drug or alcohol abuse within 1 year prior to enrollment.
27. History of hypersensitivity or life-threatening reactions to the investigational drug or any components or formulations of the investigational therapy (e.g., DMSO).
28. Any condition that, in the opinion of the investigator, may affect participation in the study, pose a safety risk to the subject, or potentially confound the interpretation of study results.研究实施时间：
Study execute time：
从
From
2026-03-05 00:00:00至
To
2029-01-01 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2026-03-19 00:00:00
至
To
2027-12-31 00:00:00干预措施：
Interventions：
组别：
试验组
样本量：
3
Group：
Test group
Sample size：
干预措施：
mRNA-LNP递送三特异性抗体为多次输注，时间分别为D0,D3,D7,D14；每次输注为2mg。
干预措施代码：
Intervention：
The mRNA-LNP-delivered trispecific antibody will be administered as multiple infusions on days 0, 3, 7, and 14, with each infusion containing 2 mg
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
广东省
市(区县)：
广州市
Country：
China
Province：
Guangdong Province
City：
Guangzhou City
单位(医院)：
广州医科大学附属第一医院
单位级别：
三甲
Institution
hospital：
The First Affiliated Hospital of Guangzhou Medical University
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
TBNK检测
指标类型：
主要指标
Outcome：
TBNK Assay
Type：
Primary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
血常规
指标类型：
次要指标
Outcome：
Complete Blood Count(CBC)
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
血压
指标类型：
次要指标
Outcome：
blood pressure
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
血生化
指标类型：
次要指标
Outcome：
Blood Biochemistry
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
疾病活动度评分
指标类型：
次要指标
Outcome：
Disease Activity Score
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
细胞因子
指标类型：
次要指标
Outcome：
Cytokines
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
免疫球蛋白
指标类型：
次要指标
Outcome：
Immunoglobulins
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
炎症指标
指标类型：
附加指标
Outcome：
Inflammatory Markers
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
药物代谢动力学
指标类型：
主要指标
Outcome：
Pharmacokinetics(PK)
Type：
Primary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
体温
指标类型：
次要指标
Outcome：
Body Temperature
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
心率
指标类型：
次要指标
Outcome：
heart rate
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
肝功能
指标类型：
次要指标
Outcome：
Liver Function
Type：
Secondary indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
凝血因子
指标类型：
附加指标
Outcome：
Coagulation Factors
Type：
Additional indicator
测量时间点：
测量方法：
Measure time point of outcome：
Measure method：
指标中文名：
尿常规
指标类型：
次要指标
Outcome：
Urinalysis
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：
Sample Name：
Blood
Tissue：
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：
尿液
组织：
Sample Name：
Urine
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
70
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）：
不适用Randomization Procedure (please state who
generates the
random number sequence and by what method)：
Not applicable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）：
不适用The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
Not applicable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：
病例记录表和his系统Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
CRF and his system数据与安全监察委员会：
Data and Safety Monitoring Committee：
暂未确定/Not yet注册人：
Name of Registration：
2026-03-19 17:42:44
