Status:
RECRUITING
A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
CRS - Cytokine Release Syndrome
Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
August 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07106671
Start Date
August 10 2025
End Date
August 1 2027
Last Update
August 6 2025
Active Locations (1)
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1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China