Status:

RECRUITING

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

Lead Sponsor:

Institute of Hematology & Blood Diseases Hospital, China

Conditions:

CRS - Cytokine Release Syndrome

Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 nervous system (CNS) involement.

Key Trial Info

Start Date :

August 10 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2027

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT07106671

Start Date

August 10 2025

End Date

August 1 2027

Last Update

August 6 2025

Active Locations (1)

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Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, China

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