Actively Recruiting
A Phase II Clinical Trial of Siltuximab for Cytokine Release Syndrome and Neurotoxicity After CAR-T Treatment in Multiple Myeloma
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-06
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Siltuximab in a Phase II clinical trial for patients with multiple myeloma who develop cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) after CAR-T cell therapy. This study aims to assess the resolution of these side effects that can occur following CAR-T treatment in this patient group. Participants who have persistent grade 1 or higher CRS or ICANS after CAR-T therapy will receive an immediate dose of Siltuximab at 11 mg/kg. If symptoms continue after 12 hours, a repeat dose of Siltuximab and corticosteroids may be given. If symptoms remain unresolved or worsen, rescue treatment with tocilizumab, corticosteroids, or other medications will be provided as needed. During the study, participants will be monitored to measure the rate of complete CRS resolution within 14 days and ICANS resolution within 28 days. Researchers will also assess safety and response to treatment. The total duration and detailed follow-up plans are not specified, but assessments will include symptom monitoring after treatment interventions.
CONDITIONS
Brief Title
A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
Who Can Participate
Eligibility Criteria
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 cytokine release syndrome (grade 1 or higher) and/or immune effector cell-associated neurotoxicity syndrome (grade 1 or higher) after CAR-T treatment.
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 greater than 3 times the upper limit of normal, or bilirubin greater than 2 times the upper limit of normal.
- Severe cardiac conditions including NYHA class III/IV heart failure, uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months, or other uncontrolled/severe cardiovascular diseases including prior cerebrovascular events with residual deficits.
- Severe comorbidities such as active infections, known active hepatitis B or C virus, HIV infection, uncontrolled diabetes, or serious conditions like 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 14 days
Participants with persistent or severe cytokine release syndrome (CRS) or neurotoxicity after CAR-T therapy receive Siltuximab drug treatment. Additional Siltuximab doses and corticosteroids may be given if symptoms persist, with rescue therapies if needed.
1 to 2 visits depending on symptom persistence
Duration - Up to 28 days
Participants are monitored for resolution of neurotoxicity and CRS after treatment.
Approximately 2 follow-up visits
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, PhD&MD
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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