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

NCT07106671 | Recruiting Phase 2

• 1 other identifier: IIT2025006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CRS - Cytokine Release Syndrome; Myeloma

Outcome Measures

Primary Outcomes (1)

• Complete CRS resolution rate

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

  14 days

Secondary Outcomes (1)

• CANS Resolution Rate

  28 day

Study Arms (1)

Siltuximab

EXPERIMENTAL

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.

Drug: Siltuximab

Interventions

Siltuximab DRUG

Siltuximab 11mg/kg

Siltuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

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

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Cytokine Release Syndrome; Neoplasms, Plasma Cell

Interventions

siltuximab

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Gang An, PhD&MD

CONTACT

86-022-23909171; angang@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

CN (1)