NCT07391605招募中2 期
A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Major improvement of 2016 ACR/EULAR Total Improvement score
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of one of the following:
- •Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)."
- •Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement.
- •Refractory or intolerance to standard therapy.
- •Stable background immunosuppressive therapy for ≥8 weeks.
- •Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).
- •Informed consent, compliance with visits, contraception, and vaccinations required.
排除标准
- •Isolated interstitial lung disease (ILD) without muscle or skin involvement
- •Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound).
- •Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension.
- •Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's).
- •Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression.
- •Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation.
- •Pregnancy or lactation.
- •Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods).
- •Live vaccination within 4 weeks.
- •History of primary immunodeficiency, organ or bone marrow transplant.
- •Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.
研究组 & 干预措施
Decartes-08
Experimental
干预措施: Descartes-08 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Major improvement of 2016 ACR/EULAR Total Improvement score
时间窗: 24 weeks
Proportion of participants in the Descartes-08 group compared with placebo who achieve major improvement marked by ≥60 point improvement on the 2016 ACR/EULAR Total Improvement Score (TIS)
次要结局
未报告次要终点
研究者
研究点 (6)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes MellitusNCT07321678Ascletis Pharma (China) Co., Limited100
招募中
2 期
Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes MellitusNCT07282743Sun Pharmaceutical Industries Limited285
尚未招募
2 期
Phase IIa Clinical Trial of YN001 in Patients With Atherosclerotic Cardiovascular and Cerebrovascular Diseases and Erectile DysfunctionErectile DysfunctionNCT07311330Beijing Inno Medicine Co., Ltd.40
尚未招募
2 期
A Phase 2 Study on the Safety and Efficacy of the Anti-BAFF-R Monoclonal Antibody, ESG206, in Patients With Primary Sjogren SyndromeNCT07375524Shanghai Escugen Biotechnology Co., Ltd40
尚未招募
2 期
Sintilimab Combined With Stereotactic Body Radiotherapy as Neoadjuvant Therapy for Resectable HepatocellularNCT07352007Lei ZHAO110