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)

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

Tianjin, China

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NCT07106671


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