NCT07642843尚未招募1 期
Evaluation of CM336 Injection for Active Sjogren's Syndrome: an Open-Label Phase Ib Study
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CM336 in adult participants with active primary Sjogren's Syndrome.
详细描述
An open-label, multicenter, multiple ascending dose study evaluating safety, tolerability,PK/ADA profile and efficacy of CM336 administered subcutaneously in active primary Sjogren's Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), and willing to comply with the study protocol requirements.
- •Body weight ≥ 45 kg at screening.
- •Voluntary compliance with the protocol requirements for permitted/prohibited concomitant therapies.
- •Definitive diagnosis of primary Sjögren's disease (SjD) according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and meeting all of the following requirements:
- •Seropositive for at least one SjD-related autoantibody.
- •Prior treatment with at least two systemic therapies for SjD symptoms.
- •Active disease at screening, defined as Clinical EULAR Sjögren's Syndrome Disease Activity Index(ClinESSDAI) ≥
- •No better therapeutic alternative available for the study participant.
排除标准
- •Presence of other systemic autoimmune diseases besides primary Sjögren's disease.
- •Presence of other autoimmune or inflammatory diseases.
- •Presence of any other medical condition with clinical manifestations overlapping with primary Sjögren's disease or that may interfere with result interpretation.
- •Presence of active, life-threatening, or organ-threatening SjD complications at screening.
- •History of severe allergic reactions (as judged by the investigator), or history of hypersensitivity to monoclonal antibodies or any component of CM
- •Presence of congenital immunodeficiency, or acquired immunodeficiency not related to the participant's autoimmune disease or its medical treatment.
- •Positive HIV antibody, positive Treponema pallidum antibody, or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •History of tuberculosis infection.
- •Active infection requiring intravenous anti-infective treatment within 3 months before first dose of study drug, or oral anti-infective treatment within 2 weeks before first dose of study drug.
- •History of disseminated herpes zoster, or ocular/Central Nervous System herpes zoster, or systemic herpes simplex or symptomatic herpes zoster infection within 3 months before first dose of study drug.
- •Deep vein thrombosis or pulmonary embolism within 6 months before first dose of study drug.
- •History of severe cardiovascular or cerebrovascular disease, including but not limited to:
- •Unstable arrhythmia, unstable angina pectoris.
- •New York Heart Association (NYHA) functional class III or IV.
- •Uncontrolled hypertension (average systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg on two measurements despite optimal treatment).
- •Fridericia-corrected QT interval(QTcF) >450 ms for males or >470 ms for females
- •History of pulmonary arterial hypertension with WHO functional class II or above.
- •Presence of uncontrolled asthma or chronic obstructive pulmonary disease (COPD); uncontrolled diabetes mellitus; uncontrolled thyroid or other endocrine disorders; uncontrolled psychiatric disorders.
- •Presence of any of the following during screening:
- •Neutrophil count <1×10⁹/L, platelet count <100×10⁹/L, or hemoglobin <80 g/L (applicable only to patients without hematologic involvement).
- •Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upper limit of normal (ULN).
- •estimated Glomerular Filtration Rate(eGFR) <40 mL/min/1.73m² (2021 Chronic Kidney Disease Epidemiology Collaboration formula).
- •Prothrombin time (PT) or activated partial thromboplastin time (APTT) >1.5×Upper Limit of Normal.
- •Major surgery within 3 months before screening or planned during the study period (requiring hospitalization and general anesthesia, excluding diagnostic procedures).
- •History of malignancy within 5 years before first dose of study drug (except cured basal cell carcinoma, squamous cell carcinoma of the skin, and cervical carcinoma in situ without evidence of recurrence).
- •Prior treatment with any anti-B-cell maturation antigen targeted therapy (including cell therapy or antibody therapy, etc.).
- •Receipt of prohibited medications within the corresponding timeframes.
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1/2 期
CM336 注射液治疗复发或难治性自身免疫性血细胞减少症受试者的 I/II 期临床研究CTR20253521158
招募中
1/2 期
CM336 注射液治疗复发或难治性自身免疫性血细胞减少症受试者的 I/II 期临床研究复发或难治性自身免疫性血细胞减少症CTR20253521康诺亚生物医药科技（成都）有限公司
尚未招募
1 期
CM336 干燥综合征Ⅰb 期研究干燥综合征CTR20261980康诺亚生物医药科技有限公司 / 成都康诺行生物医药科技有限公司
尚未招募
2 期
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax MalariaMalariaNCT07430592R. Kiplin Guy104
招募中
1 期
JMT106 Injection in the Treatment of Advanced Solid TumorsHepatocellular CarcinomaLung Squamous Cell CarcinomaNCT07275073Shanghai JMT-Bio Inc.200