MedPath

Siltuximab

Generic Name
Siltuximab
Brand Names
Sylvant
Drug Type
Biotech
CAS Number
541502-14-1
Unique Ingredient Identifier
T4H8FMA7IM
Background

Siltuximab is a chimeric (human-mouse) monoclonal immunoglobulin G1-kappa antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology. Siltuximab prevents the binding of IL-6 to soluble and membrane-bound IL-6 receptors by forming high affinity complexes with human interleukin-6 (IL-6). Its use is indicated for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. MCD is a rare blood disorder caused by dysregulated IL-6 production, proliferation of lymphocytes, and subsequent enlargement of the lymph nodes. It is administered as a 1 hour intravenous infusion every 3 weeks.

Indication

Siltuximab is indicated for the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative. Siltuximab did not bind to virally produced IL-6 in a nonclinical study and was therefore not studied in patients with MCD who are HIV or HHV-8 positive.

Associated Conditions
Castleman Disease

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Phase 2
Recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2024-11-08
Last Posted Date
2025-03-11
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
215
Registration Number
NCT06679829
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients with Advanced Cancer, CIRES Trial

Phase 2
Recruiting
Conditions
Hematopoietic and Lymphatic System Neoplasm
Advanced Malignant Solid Neoplasm
Interventions
Biological: Anti-PD-L1 Monoclonal Antibody
Biological: Anti-PD1 Monoclonal Antibody
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Scan
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Other: Quality-of-Life Assessment
First Posted Date
2024-06-24
Last Posted Date
2025-01-03
Lead Sponsor
Yuanquan Yang
Target Recruit Count
40
Registration Number
NCT06470971
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab

Phase 1
Recruiting
Conditions
Non-Hodgkin Lymphoma
Cytokine Release Syndrome
Interventions
First Posted Date
2024-06-07
Last Posted Date
2025-05-11
Lead Sponsor
Taylor Brooks
Target Recruit Count
20
Registration Number
NCT06447376
Locations
🇺🇸

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM

Phase 2
Withdrawn
Conditions
Refractory Multiple Myeloma
Multiple Myeloma
Cytokine Release Syndrome
Immune Effector Cell Associated Neurotoxicity Syndrome
Interventions
Drug: Teclistamab(FDA-approved)
First Posted Date
2024-04-08
Last Posted Date
2025-03-03
Lead Sponsor
Jack Khouri, MD
Target Recruit Count
20
Registration Number
NCT06352866
Locations
🇺🇸

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio, Cleveland, Ohio, United States

Dose-escalation of Siltuximab in Combination With Idarubicin and Cytarabine Chemotherapy in Patients With Acute Myeloblastic Leukaemia (AML) With Poor Prognosis: SILTUXILAM

Phase 1
Recruiting
Conditions
Acute Myeloid Leukemia (AML)
Interventions
First Posted Date
2023-01-26
Last Posted Date
2023-04-06
Lead Sponsor
Nantes University Hospital
Target Recruit Count
12
Registration Number
NCT05697510
Locations
🇫🇷

CHU de Nantes, Nantes, France

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Phase 2
Recruiting
Conditions
Schwannomatosis
Schwannomas
Pain, Chronic
Interventions
First Posted Date
2023-01-13
Last Posted Date
2024-03-13
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
40
Registration Number
NCT05684692
Locations
🇺🇸

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States

Siltuximab for the Prevention of CAR T Cell Related Cytokine Release Syndrome in Patients With CD19 Positive Non-Hodgkin Lymphoma

Phase 1
Completed
Conditions
Non-Hodgkin Lymphoma
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
First Posted Date
2022-12-27
Last Posted Date
2025-01-31
Lead Sponsor
Timothy Voorhees
Target Recruit Count
11
Registration Number
NCT05665725
Locations
🇺🇸

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Siltuximab in Large Granular Lymphocytic Leukemia (LGLL)

Early Phase 1
Active, not recruiting
Conditions
Large Granular Lymphocyte Leukemia
Interventions
First Posted Date
2022-04-07
Last Posted Date
2025-02-03
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
6
Registration Number
NCT05316116
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Study to Evaluate the Role of Siltuximab in Treatment of Cytokine Release Syndrome (CRS) and Immune Effector Cell Associated Neurotoxicity (ICANS) Related to CAR-T Cell Therapy

Phase 2
Recruiting
Conditions
ICANS
Lymphoma, Non-Hodgkin
Acute Lymphoblastic Leukemia
Cytokine Release Syndrome
Multiple Myeloma
Interventions
First Posted Date
2021-07-23
Last Posted Date
2025-01-28
Lead Sponsor
University of Alabama at Birmingham
Target Recruit Count
30
Registration Number
NCT04975555
Locations
🇺🇸

University of Alabama at Birmingham, Birmingham, Alabama, United States

Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease

Phase 2
Terminated
Conditions
Idiopathic Multicentric Castleman's Disease
Interventions
First Posted Date
2021-04-09
Last Posted Date
2021-04-19
Lead Sponsor
EusaPharma (UK) Limited
Target Recruit Count
22
Registration Number
NCT04838860
Locations
🇺🇸

Edward W. Sparrow Hospital, Lansing, Michigan, United States

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