NCT07106671招募中2 期
A Prospective, Single-Arm, Single-Center, Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Immune Effector Cell-Associated Neurotoxicity After CAR-T Treatment in Multiple Myeloma
Institute of Hematology & Blood Diseases Hospital, China1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年8月10日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Complete CRS resolution rate
研究概览
简要总结
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be informed and voluntarily sign the Informed Consent Form (ICF).
- •Age ≥18 years old.
- •Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
- •Developed CRS (grade ≥1) and/or ICANS (grade ≥1) after CAR-T treatment.
排除标准
- •Creatinine clearance <30 mL/min.
- •Platelet count <75,000/μL, absolute neutrophil count <1,000/μL, or hemoglobin <60 g/L at screening.
- •ALT or AST >3× ULN, or bilirubin >2× ULN.
- •Known severe cardiac conditions, including NYHA class III/IV heart failure, uncontrolled angina, arrhythmia, or hypertension, myocardial infarction within 6 months, or other uncontrolled/severe cardiovascular diseases, including prior cerebrovascular events with residual deficits.
- •Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.
- •Known intolerance to Siltuximab.
- •Known central nervous system (CNS) involement.
研究组 & 干预措施
Siltuximab
Experimental
Multiple myeloma patients with persistent grade 1 CRS/ICANS for 12 hours or grade ≥2 CRS/ICANS after CAR-T therapy will receive Siltuximab (11 mg/kg) immediately. If symptoms persist for another 12 hours, repeat Siltuximab and corticosteroids are allowed. If unresolved or worsened, rescue therapy with tocilizumab, corticosteroids, or other medications will be given.
干预措施: Siltuximab (Drug)
结局指标
主要结局
Complete CRS resolution rate
时间窗: 14 days
14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
次要结局
- CANS Resolution Rate(28 day)
研究者
研究点 (1)
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