Clinical trials: Monoclonal
Systemic Lupus Erythematosus
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
This is a continuation study to evaluate the long-term safety and efficacy of LymphoStat-B™ in subjects with SLE disease, that completed study LBSL02 and benefitted from treatment.
- Trial name
- NCT00583362
- Testing
- Belimumab
- Where
- 57 sites in United States, Canada
- Volunteers
- 298 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Autoimmune Diseases, Renal Disorders
Evaluation of Therapeutic Plasma Exchange (TPE) Procedure Using the AMICUS Device
This study will evaluate the use of the AMICUS device in patients where Therapeutic Plasma Exchange (TPE) is prescribed by their physicians.
- Conditions
- Autoimmune Diseases, Renal Disorders, Hematologic Disorders, Oncologic Disorders
- Trial name
- NCT01210716
- Testing
- Therapeutic plasma exchange
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- Fenwal, Inc.
Arthritis, Osteoarthritis
Tanezumab In Osteoarthritis Of The Knee (2)
The purpose of this study is to test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis.
- Trial name
- NCT00830063
- Testing
- tanezumab 10 mg, tanezumab 5 mg, naproxen
- Where
- 94 sites in United States
- Volunteers
- 832 people
- Sponsor
- Pfizer
Advanced Gastrointestinal Tumors
A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.
The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.
- Trial name
- NCT01916447
- Testing
- TAS-102, CPT-11, Bevacizumab
- Where
- 4 sites in United States
- Volunteers
- 65 people
- Sponsor
- Taiho Oncology, Inc.
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
This is a Phase II, multi-site, open-label, parallel group study in participants with untreated extended-stage small-cell lung cancer (ES-SCLC) (Cohort 1) or small-cell lung cancer (SCLC) which has progressed on first- or…
- Trial name
- NCT06449209
- Testing
- BNT327 Dose Level 1 (DL1), BNT327 Dose Level 2 (DL2), Etoposide
- Where
- 64 sites in United States, Australia and 3 more
- Volunteers
- 110 people
- Sponsor
- BioNTech SE
Plasma Cell Myeloma Refractory
A Study to Investigate the Safety and Efficacy of SAR446523 Injected Subcutaneously in Adult Participants With Relapsed/Refractory Myeloma
This is a first-in-human study of SAR446523 conducted in patients with RRMM. The study consists of two parts: Dose escalation (Part A): In this part, up to several dose levels (DLs) of SAR446523 will be explored to determine the…
- Trial name
- NCT06630806
- Testing
- SAR446523
- Where
- 19 sites in United States, Australia and 5 more
- Volunteers
- 87 people
- Sponsor
- Sanofi
Solid Tumor, Adult
FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.
- Trial name
- NCT05069935
- Testing
- FT538, Cyclophosphamide, Fludarabine
- Where
- 4 sites in United States
- Volunteers
- 16 people
- Sponsor
- Fate Therapeutics
Advanced Solid Tumor, Lymphoma
A Study of GRC 54276 in Participants With Advanced Solid Tumors and Lymphomas.
This is first in human (FIH) study to a) evaluate the safety and tolerability profile of GRC54276, b) determine the maximum tolerated dose (MTD) and recommended Phase 2 doses (RP2D), and c) pharmacokinetic profile of GRC54276…
- Trial name
- NCT05878691
- Testing
- GRC 54276, GRC 54276 + Pembrolizumab, GRC 54276 + Atezolizumab
- Where
- 18 sites in United States, India
- Volunteers
- 320 people
- Sponsor
- Glenmark Specialty S.A.
Multiple Sclerosis, Relapsing-Remitting
Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis
The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis.
- Trial name
- ANGEL-MS (NCT03239860)
- Testing
- GNbAC1 Monoclonal Antibody
- Where
- 12 sites in Bulgaria, Croatia and 10 more
- Volunteers
- 220 people
- Sponsor
- GeNeuro SA
Ulcerative Colitis (UC)
Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- ULTRAMARINE (NCT07080034)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 198 people
- Sponsor
- Biocad
Hepatocellular Carcinoma
A Study of Mapatumumab in Combination With Sorafenib in Subjects With Advanced Hepatocellular Carcinoma
The purpose of this study is to evaluate the safety and tolerability of escalating doses of mapatumumab in combination with sorafenib in subjects with advanced Hepatocellular Carcinoma who are positive for hepatitis B surface…
- Trial name
- HCC (NCT00712855)
- Testing
- mapatumumab, sorafenib
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Human Genome Sciences Inc., a GSK Company
Axial Spondyloarthritis
Study of the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of BCD-180 in Patients With Axial Spondyloarthritis (LEVENTA)
The aim of the study is to evaluate the efficacy, safety, immunogenicity, pharmacokinetics and pharmacodynamics of a fixed dose of study drug (BCD-180) in comparison with placebo in patients with active axial spondyloarthritis…
- Trial name
- NCT06333210
- Testing
- anti-TRBV9 monoclonal antibody infusions, Adalimumab subcutaneous injection
- Where
- 32 sites in Belarus, Russia
- Volunteers
- 421 people
- Sponsor
- Biocad
Mantle Cell Lymphoma (MCL)
A Phase II Study of TT-01488 Tablets in Combination With Anti-CD20 Monoclonal Antibody Therapy in Patients With Mantle Cell Lymphoma
This is a multicenter, open-label, phase II study evaluating TT-01488 in combination with different anti-CD20 monoclonal antibody-containing regimens for the treatment of treatment-naïve mantle cell lymphoma (MCL).
- Trial name
- NCT07855016
- Testing
- TT-01488 Tablets, Rituximab, Immunomodulatory Agent
- Where
- 2 sites in China
- Volunteers
- 188 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
Psoriasis
A Phase 3 Study of Recombinant Anti-IL-17A Humanized Monoclonal Antibody in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
The purpose of this study is to determine the efficacy and safety of the study drug recombinant anti-IL-17A humanized monoclonal antibody in Chinese participants with moderate-to-severe plaque psoriasis.
- Trial name
- NCT05536726
- Testing
- 608 Q2W, 608 Q4W
- Where
- China
- Volunteers
- 458 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Carcinomas, Disease, Hodgkin
Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)
The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion.
- Conditions
- Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin
- Trial name
- NCT01026415
- Testing
- brentuximab vedotin, rifampin, midazolam
- Where
- 6 sites in United States
- Volunteers
- 73 people
- Sponsor
- Seagen Inc.
Metastatic Colorectal Cancer
Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients
This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented…
- Trial name
- NCT02965417
- Testing
- Sym004
- Sponsor
- Symphogen A/S
Ventilator Associated Pneumonia, Staphylococcus Aureus
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
Clinical trial looking at safety and efficacy of suvratoxumab in prevention of pneumonia caused by Staphylococcus aureus in high-risk patients
- Trial name
- SAATELLITE-2 (NCT05331885)
- Testing
- Suvratoxumab
- Where
- 27 sites in Belgium, France and 4 more
- Volunteers
- 24 people
- Sponsor
- Aridis Pharmaceuticals, Inc.
Type 1 Diabetes Mellitus
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS)
This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on…
- Trial name
- FABULINUS (NCT06111586)
- Testing
- Frexalimab, Insulin
- Where
- 79 sites in United States, Austria and 14 more
- Volunteers
- 197 people
- Sponsor
- Sanofi
Peripheral T-Cell Lymphoma
Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma
This study will determine the maximum dose of KW-0761 administered intravenously that can be given safely in subjects with previously treated peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma(CTCL)and will see if it…
- Trial name
- NCT00888927
- Testing
- KW-0761
- Where
- 5 sites in United States
- Volunteers
- 42 people
- Sponsor
- Kyowa Kirin Co., Ltd.
End Stage Kidney Disease (ESKD)
A Phase 1b Study to Evaluate the PK of CSL300 (Clazakizumab) in Chinese Subjects With End Stage Kidney Disease (ESKD)
This is a phase 1b, partial-blind (Sponsor unblinded), randomized, multicenter, placebo-controlled study. The primary objective of this study is to evaluate the pharmacokinetics (PK) of CSL300 after single and multiple doses in…
- Trial name
- NCT07619820
- Testing
- CSL300
- Where
- China
- Volunteers
- 24 people
- Sponsor
- CSL Behring
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