NCT07106671 A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
| NCT ID | NCT07106671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | CRS - Cytokine Release Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2026-08-01 |
Trial Parameters
Eligibility Fast-Check
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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: 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 nerv