Institute of Hematology & Blood Diseases Hospital, China
Phase
Phase 2
Started
2025-08-10
Last updated
2025-08-06
Condition(s) studied
CRS - Cytokine Release SyndromeMyeloma
Investigational drug(s) / intervention(s)
Siltuximab
Siltuximab: Siltuximab 11mg/kg
Study summary
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Be informed and voluntarily sign the Informed Consent Form (ICF).
2. Age ≥18 years old.
3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
4. Developed CRS (grade ≥1) and/or ICANS (grade ≥1) after CAR-T treatment.
Exclusion Criteria:
1. Creatinine clearance \<30 mL/min.
2. Platelet count \<75,000/μL, absolute neutrophil count \<1,000/μL, or hemoglobin \<60 g/L at screening.
3. ALT or AST \>3× ULN, or bilirubin \>2× ULN.
4. 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.
5. Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.
6. Known intolerance to Siltuximab.
7. Known central nervous system (CNS) involement.
Primary outcome measure(s)
Complete CRS resolution rate — 14 days 14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
Trial sites (1)
Facility
City
Region
Status
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin
China
Recruiting
More Institute of Hematology & Blood Diseases Hospital, China trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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