RecruitingPhase 2NCT07106671
A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
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
Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Enrollment
20 participants
Start Date
Aug 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- 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 Criteria7
- 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.
Interventions
DRUGSiltuximab
Siltuximab 11mg/kg
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07106671
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