What is Siltuximab studying for cytokine release syndrome and ICANS after CAR-T therapy in multiple myeloma?

Siltuximab is being studied to see if it can help resolve cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) that sometimes occur after CAR-T treatment in multiple myeloma patients. This research aims to better manage these side effects. The trial is sponsored by the Institute of Hematology & Blood Diseases Hospital in China.

Who may be eligible for this cytokine release syndrome and ICANS clinical trial?

Adults aged 18 years or older with multiple myeloma who have developed CRS or ICANS after CAR-T therapy may be eligible. There is no gender restriction. Key factors include sufficient kidney function, blood counts, and no severe heart or active infections. Please review eligibility criteria for more details.

Is there any cost to participate in this cytokine release syndrome and ICANS clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered during the trial.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07106671

Phase II Study of Siltuximab to Treat Cytokine Release Syndrome and Neurotoxicity After CAR-T Therapy in Multiple Myeloma Patients

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

Participants Needed

Research Sites

52 weeks

Total Duration

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 mgkg. 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

Age: 18Years +

All Genders

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.

Research Team

Gang An, PhD&MD

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