NCT07106671RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 10 Aug 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Diseases
- Multiple myeloma
- NCT number
- NCT07106671
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 10 Aug 2025 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Severe comorbidities, including active infections, known active HBV/HCV, HIV infection, uncontrolled diabetes, or serious conditions like chronic restrictive lung disease or cirrhosis.
Lab values
- 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.
Other
- Known intolerance to Siltuximab.
- Known central nervous system (CNS) involement.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.