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NCT Number: NCT07106671

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

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

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Key information

Conditions

CRS - Cytokine Release Syndrome Cytokine Release Syndrome Inflammation Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Tianjin, China

Location status: Recruiting

Location contact

Gang An

CONTACT

[email protected]

86-022-23909171

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Siltuximab

Drug

Siltuximab 11mg/kg

Primary outcomes

  1. Complete CRS resolution rate

    Time frame: 14 days

    14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours

Secondary outcomes

  1. CANS Resolution Rate

    Time frame: 28 day

    28-day ICANS Resolution Rate

Study contacts

Contact information is provided by the study sponsor or research team.

Gang An, PhD&MD

CONTACT

[email protected]

86-022-23909171

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 6, 2025
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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