Clinical trials: Immunoglobulin
Primary Immune Deficiency Disorder
A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products
This is a safety study to evaluate the risk of low blood pressure in subjects with Primary Immune Deficiency disorder (PID) treated with Bivigam™ or another commercial product under real world conditions.
- Trial name
- NCT03037359
- Testing
- Bivigam, Other
- Where
- 17 sites in United States
- Volunteers
- 200 people
- Sponsor
- ADMA Biologics, Inc.
Platinum-resistant Ovarian Cancer
An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
- Trial name
- RAINFOL-02 (NCT07604766)
- Testing
- Rina-S, Paclitaxel, Topotecan
- Where
- 17 sites in China
- Volunteers
- 82 people
- Sponsor
- Genmab
Amyotrophic Lateral Sclerosis, Motor Neuron Disease
IC14 for Treatment of Amyotrophic Lateral Sclerosis
Fifty patients with amyotrophic lateral sclerosis that is progressing rapidly will be randomized to receive either the monoclonal antibody IC14 or placebo to be given intravenously over two hours twice weekly for 12 weeks.
- Trial name
- NCT03508453
- Testing
- IC14
- Where
- Australia
- Sponsor
- Implicit Bioscience
Solid Tumor, Adult
A Study of BI-1206 in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcγRIIB), in Combination with Pembrolizumab in Subjects with Advanced Solid Tumors
- Trial name
- NCT04219254
- Testing
- BI1206
- Where
- 26 sites in United States, Georgia and 5 more
- Volunteers
- 197 people
- Sponsor
- BioInvent International AB
Solid Tumor
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody) in Patients With Solid Tumors
This is a first-in-human (FIH), phase 1/2, multi center, open-label, dose escalation and cohort expansion study designed to determine the safety and tolerability of PRS-344/S095012 in patients with advanced and/or metastatic…
- Trial name
- NCT05159388
- Testing
- PRS-344/S095012
- Where
- 11 sites in United States, Australia and 2 more
- Volunteers
- 46 people
- Sponsor
- Servier Bio-Innovation LLC
Crohn Disease
An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease
The purpose of this study is to evaluate the effectiveness and safety of anti-TNF chimeric monoclonal antibody (cA2) compared to placebo in patients with active Crohn's disease.
- Trial name
- NCT00269854
- Testing
- Infliximab 5 mg/kg, Infliximab 10 mg/kg, Infliximab 20 mg/kg
- Volunteers
- 108 people
- Sponsor
- Centocor, Inc.
HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastrointestinal Cancers, Including Gastroesophageal Adenocarcinoma, Biliary Tract Cancer, and Colorectal Cancer
This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) plus standard first-line combination chemotherapy regimens for…
- Trial name
- NCT03929666
- Testing
- ZW25 (Zanidatamab), Capecitabine, Cisplatin
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 74 people
- Sponsor
- Jazz Pharmaceuticals
Biliary Tract Cancer
A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer
This is a Phase Ib, open-label,single-arm, clinical study, aiming to investigate the safety, tolerability and pharmacokinetics of ZKAB001 (a fully human monoclonal antibody targeting the Programmed Death - Ligand 1 (PD-L1)…
- Trial name
- NCT04608786
- Testing
- ZKAB001 5mg/kg, Capecitabine
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lee's Pharmaceutical Limited
Giant Cell Arteritis (GCA)
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)
This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)
- Trial name
- GCAptAIN (NCT04930094)
- Testing
- Secukinumab 300 mg, Secukinumab 150 mg
- Where
- 104 sites in United States, Argentina and 25 more
- Volunteers
- 354 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced Solid Tumor
Phase 1/2 Study of OBI-999 in Patients With Advanced Solid Tumors
The purpose of this study is to establish the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of OBI-999 as monotherapy, and to characterize the safety and preliminary clinical activity profile of the RP2D of…
- Trial name
- NCT04084366
- Testing
- OBI-999
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- OBI Pharma, Inc
Meningoccocal Disease
Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine
This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.
- Trial name
- PERS-ACYWX-03 (NCT07379151)
- Where
- 2 sites in Mali, The Gambia
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Postmenopausal Osteoporosis, Low Bone Mass
Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone Mass
This is a randomized, double-blind, placebo- and active-controlled Phase II study evaluating the efficacy and safety of TST002 injection (a humanized monoclonal antibody) in postmenopausal women with osteoporosis or low bone…
- Trial name
- NCT07806331
- Testing
- Denosumab
- Volunteers
- 110 people
- Sponsor
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
Solid Tumor, Adult
A Study of HLX06, a Humanized Monoclonal Antibody Targeting Human Vascular Endothelial Growth Factor Receptor-2 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of fully human anti-VEGFR2 monoclonal antibody, HLX06, in patients with advanced or metastatic tumors refractory to…
- Trial name
- NCT03494231
- Testing
- HLX06
- Where
- Taiwan
- Volunteers
- 5 people
- Sponsor
- Henlix, Inc
Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma
A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
- Conditions
- Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney Neoplasms
- Trial name
- NCT02837991
- Testing
- CDX-014
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Celldex Therapeutics
Breast Cancer
A Safety and Efficacy Study of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
The purpose of the study is to determine the overall response to a combination of bavituximab and docetaxel in patients with advanced breast cancer
- Trial name
- NCT00669591
- Testing
- Bavituximab
- Where
- 4 sites in Georgia
- Volunteers
- 46 people
- Sponsor
- Peregrine Pharmaceuticals
Multiple Myeloma, Secondary Immunodeficiency
A Study of Gammagard Liquid (Immune Globulin Infusion, 10%) to Prevent Infections in Adults With Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells in the bone marrow. The main aim of this study is to learn how well the Immune Globulin Infusion (human), 10 percentage (%) (IGI, 10%) can help prevent infections in participants…
- Trial name
- NCT06980480
- Testing
- IGI, 10%
- Where
- 65 sites in United States, Australia and 15 more
- Volunteers
- 183 people
- Sponsor
- Takeda
Triple-Negative Breast Cancer (TNBC)
A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with…
- Trial name
- NCT07729956
- Testing
- BL-B01D1, PD-1 monoclonal antibody, Nab-paclitaxel
- Where
- China
- Volunteers
- 436 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Salivary Immunity
Salivary Immunoglobulin A (sIgA) Normal Range Study
Salivary Immunoglobulin A (sIgA) is a marker of immune system activity. Typically, sIgA is determined by an ELISA test in which samples have to be sent to a specialized laboratory for testing.
- Trial name
- sIgA (NCT06248788)
- Testing
- PoC Device
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- 4Life Research, LLC
Unresectable Melanoma, Metastatic Melanoma
A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma
This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of sotigalimab (APX005M) administered at 2 different schedules to adult participants with unresectable or…
- Conditions
- Unresectable Melanoma, Metastatic Melanoma, Cancer, Cancer of Skin
- Trial name
- NCT04337931
- Testing
- sotigalimab
- Where
- 19 sites in Poland, Spain
- Volunteers
- 45 people
- Sponsor
- Apexigen America, Inc.
Primary Immunoglobulin A Nephropathy (IgAN)
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A…
- Trial name
- NCT06994845
- Testing
- iptacopan
- Where
- 20 sites in United States, Argentina and 6 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
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