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

Not Applicable

Recruiting

• Conditions: CRS - Cytokine Release Syndrome; Myeloma
• Interventions: Drug: Siltuximab

• Registration Number: NCT07106671
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Study Start: 2025-08-10
• Primary Completion: 2026-08-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Be informed and voluntarily sign the Informed Consent Form (ICF).
2. Age ≥18 years old.
3. Diagnosed with multiple myeloma according to IMWG diagnostic criteria.
4. Developed CRS (grade ≥1) and/or ICANS (grade ≥1) after CAR-T treatment.

Exclusion Criteria

1. Creatinine clearance <30 mL/min.
2. Platelet count <75,000/μL, absolute neutrophil count <1,000/μL, or hemoglobin <60 g/L at screening.
3. ALT or AST >3× ULN, or bilirubin >2× ULN.
4. 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.
5. Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.
6. Known intolerance to Siltuximab.
7. Known central nervous system (CNS) involement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Siltuximab	Siltuximab	Multiple myeloma patients with persistent grade 1 CRS/ICANS for 12 hours or grade ≥2 CRS/ICANS after CAR-T therapy will receive Siltuximab (11 mg/kg) immediately. If symptoms persist for another 12 hours, repeat Siltuximab and corticosteroids are allowed. If unresolved or worsened, rescue therapy with tocilizumab, corticosteroids, or other medications will be given.

Primary Outcome Measures

Name	Time	Method
Complete CRS resolution rate	14 days	14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours

Secondary Outcome Measures

Name	Time	Method
CANS Resolution Rate	28 day	28-day ICANS Resolution Rate

Trial Locations

Locations (1)

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, China