Drugs / Siltuximab
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Siltuximab

also known as CNTO328 · CLLB8 · Sylvant

Monoclonal antibody targets IL6 via inhibition

Developed for
plasma cell myeloma · cytokine release syndrome · non-Hodgkin lymphoma · prostate cancer · multicentric Castleman disease · renal cell carcinoma · acute myeloid leukemia · adult acute respiratory distress syndrome
+21 more · AL amyloidosis · cancer · Castleman disease · chronic pain syndrome · colorectal neoplasm · COVID-19 · head and neck neoplasm · hematopoietic and lymphoid system neoplasm · lung neoplasm · monoclonal gammopathy of uncertain significance · myelodysplastic syndrome · myelofibrosis · ovarian neoplasm · pancreatic adenocarcinoma · pancreatic neoplasm · schwannomatosis · smoldering plasma cell myeloma · T-cell large granular lymphocyte leukemia · transplant rejection · idiopathic multicentric Castleman disease · schizophrenia
Investigated by
Centocor, Inc. · Janssen Research & Development, LLC · National Cancer Institute (NCI) · RECORDATI GROUP · EUSA Pharma, Inc. · Memorial Sloan Kettering Cancer Center
+27 more · SWOG Cancer Research Network · AbbVie · Carla Greenbaum, MD · Emory University · Genmab · H. Lee Moffitt Cancer Center and Research Institute · Institute of Hematology & Blood Diseases Hospital, China · Jack Khouri, MD · Janssen Pharmaceutical K.K. · Janssen Scientific Affairs, LLC · Janssen Services, LLC · Judit Pich Martínez · M.D. Anderson Cancer Center · Massachusetts General Hospital · Nantes University Hospital · National Heart, Lung, and Blood Institute (NHLBI) · National Institutes of Health (NIH) · Northwestern University · Novartis · Syneos Health · Taylor Brooks · Timothy Voorhees · United States Department of Defense · University of Alabama at Birmingham · University of Utah · Washington University School of Medicine · Yuanquan Yang

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Sylvant 2014-05-22 europa.eu
Approved US (FDA) SYLVANT 2014-04-23 fda.gov

Trials 36 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT05316116 Feb 2023 → Oct 2024 T-cell large granular lymphocyte leukemia H. Lee Moffitt Cancer Center and Research Institute Terminated No outcome recorded
Phase 0 NCT02805868 Jun 2016 → Feb 2019 acquired polycythemia vera, myelofibrosis, primary myelofibrosis, thrombocytopenia Northwestern University Withdrawn No outcome recorded
Phase 0 NCT02641522 Mar 2016 → Mar 2017 type 1 diabetes mellitus Carla Greenbaum, MD Completed No outcome recorded
Phase 19 trials
Phase 1 NCT06990711 Nov 2025 → Dec 2027 expected transplant rejection Washington University School of Medicine Recruiting No outcome recorded
Phase 1 NCT06447376 Jan 2025 → Sep 2028 expected cytokine release syndrome, non-Hodgkin lymphoma Taylor Brooks Recruiting No outcome recorded
Phase 1 NCT05697510 Mar 2023 → Jun 2025 acute myeloid leukemia Nantes University Hospital Unknown No outcome recorded
Phase 1 NCT05665725 Jan → Sep 2023 non-Hodgkin lymphoma Timothy Voorhees Completed No outcome recorded
Phase 1 NCT01309412 Jan 2011 → Dec 2012 plasma cell myeloma Janssen Pharmaceutical K.K. Terminated No outcome recorded
Phase 1 NCT01219010 Oct 2010 → Jun 2012 monoclonal gammopathy of uncertain significance, plasma cell myeloma Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT02074800 Jun 2008 → Jun 2009 Centocor, Inc. Completed No outcome recorded
Phase 1 NCT00401765 Sep 2005 → Nov 2009 prostate cancer Centocor, Inc. Completed No outcome recorded
Phase 1 NCT00412321 May 2005 → Apr 2011 Castleman disease, non-Hodgkin lymphoma, plasma cell myeloma Centocor, Inc. Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT04191421 Jan 2020 → Apr 2023 pancreatic adenocarcinoma Emory University Completed No outcome recorded
Phase 1/2 NCT01531998 May 2012 → May 2014 plasma cell myeloma M.D. Anderson Cancer Center Completed No outcome recorded
Phase 1/2 NCT00841191 Mar 2009 → Apr 2011 colorectal neoplasm, head and neck neoplasm, lung neoplasm, ovarian neoplasm +1 Centocor, Inc. Completed No outcome recorded
Phase 1/2 NCT00265135 Aug 2003 → Feb 2006 renal cell carcinoma Centocor, Inc. Completed No outcome recorded
Phase 218 trials
Phase 2 NCT07106671 Aug 2025 → Aug 2026 overdue cytokine release syndrome, plasma cell myeloma Institute of Hematology & Blood Diseases Hospital, China Recruiting No outcome recorded
Phase 2 NCT06352866 Jan → Apr 2025 cytokine release syndrome, plasma cell myeloma Jack Khouri, MD Withdrawn No outcome recorded
Phase 2 NCT06679829 Nov 2024 → Nov 2027 expected plasma cell myeloma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06470971 Jul 2024 → Dec 2026 expected cancer, hematopoietic and lymphoid system neoplasm Yuanquan Yang Recruiting No outcome recorded
Phase 2 NCT05684692 Aug 2023 → Nov 2026 expected chronic pain syndrome, schwannomatosis Massachusetts General Hospital Recruiting No outcome recorded
Phase 2 NCT04975555 Nov 2021 → Jan 2026 acute lymphoblastic leukemia, cytokine release syndrome, plasma cell myeloma University of Alabama at Birmingham Completed No outcome recorded
Phase 2 NCT04329650 Apr 2020 → Feb 2021 COVID-19 Judit Pich Martínez Completed No outcome recorded
Phase 2 NCT03315026 Dec 2017 → Oct 2026 expected AL amyloidosis, plasma cell myeloma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT01484275 Mar 2012 → May 2015 smoldering plasma cell myeloma Janssen Research & Development, LLC Completed No outcome recorded
Phase 2 NCT01513317 Nov 2011 → Sep 2012 myelodysplastic syndrome Janssen Research & Development, LLC Terminated No outcome recorded
Phase 32 trials
Phase 3 NCT04616586 Nov 2020 → Apr 2021 adult acute respiratory distress syndrome, pneumonia RECORDATI GROUP Terminated No outcome recorded
Phase 3 NCT01266811 Jul 2011 → Apr 2014 plasma cell myeloma Centocor, Inc. Withdrawn No outcome recorded
Also used as a comparator or background therapy in 5 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT02796859 Comparator May 2016 → Dec 2023 schizophrenia Brian Miller Unknown No outcome recorded
Phase 22 trials
Phase 2 NCT07709000 Background Aug 2026 → Nov 2033 expected chronic lymphocytic leukemia/small lymphocytic lymphoma Merck Sharp & Dohme LLC Not yet recruiting No outcome recorded
Phase 2 NCT04838860 Comparator Mar → Apr 2021 idiopathic multicentric Castleman disease RECORDATI GROUP Terminated No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07570173 Background May 2026 → Oct 2033 expected B-cell acute lymphoblastic leukemia Merck Sharp & Dohme LLC Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT04330638 Comparator Apr → Dec 2020 COVID-19 University Hospital, Ghent Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 43 sources stand behind the page.

FieldValueCited text
Known as siltuximab “Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleukin-6, in chemotherapy-pretreated patients with...” PMID 20484019 May 2010
35

Siltuximab is a monoclonal antibody that blocks interleukin-6 (IL-6) from binding to its receptor, preventing it from acting.” NCT06447376

“A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors” NCT00841191

NCT05665725

NCT03315026

NCT02641522

NCT00911859

NCT06352866

NCT07709000

NCT02805868

NCT05684692

NCT04191421

NCT01513317

NCT00401843

NCT01484275

NCT04616586

NCT01024036

NCT06990711

NCT01400503

NCT00402181

NCT06679829

NCT00385827

NCT01219010

NCT07570173

NCT05697510

NCT04838860

NCT04975555

NCT06470971

NCT01531998

NCT04330638

NCT02796859

NCT04329650

NCT01266811

NCT07106671

NCT05316116

NCT01309412

Known as CLLB8 ChEMBL registry synonym — accepted as the source's own label CHEMBL1743070
Known as CNTO328 “Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleukin-6, in chemotherapy-pretreated patients with...” PMID 20484019 May 2010
10

“A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors” NCT00841191

“This is a research study with an experimental drug called siltuximab (also known as CNTO 328).” NCT01219010

“This is a research study with an experimental drug called siltuximab (also known as CNTO 328).” NCT01266811

“A Phase 1 Study of CNTO 328 (Siltuximab) in Relapsed or Refractory Multiple Myeloma” NCT01309412

NCT00265135

NCT00311545

NCT00412321

NCT00401765

NCT00433446

NCT02074800

Known as Sylvant ChEMBL registry synonym — accepted as the source's own label CHEMBL1743070
Action Inhibit “anti-IL-6 monoclonal antibody” NCT00265135
Modality Monoclonal antibody “anti-IL-6 monoclonal antibodyNCT00265135
Route Intravenous “4 intravenous infusions (IV)” NCT00265135
Target IL6 “anti-IL-6 monoclonal antibody” NCT00265135