Siltuximab treatment for CRS and 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

We will test whether siltuximab helps adults with multiple myeloma who develop CRS or ICANS after receiving CAR‑T therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: Siltuximab, CAR-T
• Locations: 1 site (Tianjin)
• Trial ID: NCT07106671 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with multiple myeloma who develop grade ≥1 CRS and/or ICANS after CAR‑T and who meet laboratory and organ‑function criteria without the listed exclusions.

Not a fit: Patients with severe organ dysfunction, uncontrolled active infections, known intolerance to siltuximab, or profound cytopenias are unlikely to benefit or be eligible for this treatment.

Why it matters

Potential benefit: If successful, siltuximab could shorten or reduce the severity of CRS/ICANS episodes and help patients recover more quickly after CAR‑T therapy.

How similar studies have performed: Blocking the IL‑6 pathway with agents like tocilizumab is an established treatment for CRS, while siltuximab has been used in smaller case series but lacks large randomized evidence for CRS/ICANS.

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 nervous system (CNS) involement.

Where this trial is running

Tianjin

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

Study contacts

• Study coordinator: Gang An, PhD&MD

Conditions CRS - Cytokine Release Syndrome; Myeloma