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

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called siltuximab to treat serious side effects — cytokine release syndrome (CRS) and immune cell-related brain inflammation (ICANS) — that can happen after CAR-T cell therapy in multiple myeloma patients. CAR-T therapy uses a patient's own immune cells to fight cancer, but can sometimes cause dangerous inflammation. **You may be eligible if:** - You are 18 or older - You have multiple myeloma - You developed CRS or ICANS (grade 1 or higher) after receiving CAR-T cell therapy **You may NOT be eligible if:** - Your kidney function is significantly reduced (creatinine clearance below 30 mL/min) - Your blood counts (platelets, white blood cells, or hemoglobin) are too low - Your liver enzyme or bilirubin levels are too high - You have serious heart disease or had a heart attack in the last 6 months - You have severe infections or other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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