NCT07106671 A Phase II Study of Siltuximab for CRS/ICANs After CAR-T in Multiple Myeloma
| NCT ID | NCT07106671 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | CRS - Cytokine Release Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-08-10 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-08-10 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07106671 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying CRS - Cytokine Release Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07106671 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07106671 currently recruiting?
Yes, NCT07106671 is actively recruiting participants. Contact the research team at angang@ihcams.ac.cn for enrollment information.
Where is the NCT07106671 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07106671 clinical trial?
NCT07106671 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 20 participants.