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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a prospective Phase II study evaluating Siltuximab for CRS and ICANS after CAR-T infusion in multiple myeloma patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
RECRUITING
Tianjin
Contact Information
Primary
Gang An, PhD&MD
angang@ihcams.ac.cn
86-022-23909171
Time Frame
Start Date: 2025-08-10
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 20
Treatments
Experimental: Siltuximab
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.
Related Therapeutic Areas
Sponsors
Leads: Institute of Hematology & Blood Diseases Hospital, China