Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07106671

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

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06

20

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be informed and voluntarily sign the Informed Consent Form (ICF).
  • Age 18 years or older.
  • Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
  • Developed CRS (grade 1 or higher) and/or ICANS (grade 1 or higher) after CAR-T treatment.
Not Eligible

You will not qualify if you...

  • Creatinine clearance less than 30 mL/min.
  • Platelet count below 75,000/µL, absolute neutrophil count below 1,000/µL, or hemoglobin below 60 g/L at screening.
  • ALT or AST levels greater than 3 times the upper limit of normal, or bilirubin greater than 2 times the upper limit of normal.
  • Known severe cardiac conditions including NYHA class III/IV heart failure, uncontrolled angina, arrhythmia, hypertension, myocardial infarction within 6 months, or other severe cardiovascular diseases including prior cerebrovascular events with residual deficits.
  • Severe comorbidities including active infections, known active hepatitis B or C, HIV infection, uncontrolled diabetes, chronic restrictive lung disease, or cirrhosis.
  • Known intolerance to Siltuximab.
  • Known central nervous system involvement.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Tianjin, China

Actively Recruiting

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Research Team

G

Gang An, PhD&MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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