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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07106671

Enrollment

Registered

2025-08-06

Start date

2025-08-10

Completion date

2027-08-01

Last updated

2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CRS - Cytokine Release Syndrome, Myeloma

Brief summary

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

Interventions

DRUGSiltuximab

Siltuximab 11mg/kg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Complete CRS resolution rate	14 days	14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours

Secondary

Measure	Time frame	Description
CANS Resolution Rate	28 day	28-day ICANS Resolution Rate

Countries

China

Contacts

Primary ContactGang An, PhD&MD

angang@ihcams.ac.cn86-022-23909171

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026