Clinical trial · Interventional
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
NCT07106671CI-TRIAL-00093138recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CRS - Cytokine Release Syndrome | — | UNRESOLVED | — |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Siltuximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Siltuximab
- description
- 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.
- interventionNames
- Drug: Siltuximab
Primary outcomes (1)
- measure
- Complete CRS resolution rate
- timeFrame
- 14 days
- description
- 14-day Complete CRS Resolution Rate: No CRS Symptoms for 24 Consecutive Hours
Secondary outcomes (1)
- measure
- CANS Resolution Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.