Siltuximab treatment for CRS and ICANS after CAR‑T in multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑center Phase II interventional study administering siltuximab, an anti–IL‑6 antibody, to patients who develop cytokine release syndrome (CRS) and/or immune effector cell‑associated neurotoxicity syndrome (ICANS) after CAR‑T infusion for multiple myeloma. Eligible adults have a diagnosis of multiple myeloma by IMWG criteria and experienced CRS or ICANS of grade 1 or higher following CAR‑T. Key exclusions include significant renal dysfunction, severe cytopenias, marked liver enzyme or bilirubin elevations, active serious infections or viral hepatitis/HIV, significant cardiac disease, and known intolerance to siltuximab. The study is led by the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences in Tianjin and follows a predefined dosing and safety monitoring plan to observe clinical response and adverse events.

Why it matters

Who can join: the full rules

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.

Where it's running

• Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Gang An, PhD&MD
• Email: angang@ihcams.ac.cn
• Phone: 86-022-23909171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.