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

Recruiting now · Phase 2

Conditions studied: CRS - Cytokine Release Syndrome, Myeloma

In brief

This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.

Key facts

Study ID

NCT07106671

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

20

Starts

2025-08-10

Expected to finish

2027-08-01

Last updated by the study team

2025-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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