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Clinical Trials in China / NCT07106671
Recruiting Phase 2

A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma

NCT07106671 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (1)

FacilityCityRegionStatus
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

Official registry record

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.

View NCT07106671 on ClinicalTrials.gov ↗ ← All trials in China