Clinical trials: Antibody
Gastroesophageal-junction Cancer, Monoclonal Antibody
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with…
- Conditions
- Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
- Trial name
- NCT06532006
- Testing
- HLX22, Pembrolizumab, Trastuzumab
- Where
- 208 sites in United States, Argentina and 15 more
- Volunteers
- 550 people
- Sponsor
- Shanghai Henlius Biotech
Generalized Myasthenia Gravis, Anti-AChR Antibody Positive
Early Ravulizumab Treatment Of Anti- AChR Antibody-Positive Generalized Myasthenia Gravis
The primary objective of the study is to evaluate the effectiveness of Ravulizumab in improving MG-ADL in an early-stage AChR+ gMG population.
- Trial name
- NCT06967480
- Testing
- Ravulizumab
- Where
- 23 sites in Italy
- Volunteers
- 40 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Antineutrophil Cytoplasmic Antibody (ANCA) -Associated Vasculitis (AAV)
An Exploratory Study of MT-2990 in Patients With AAV
To explore the efficacy, safety, pharmacokinetics and mechanism of action of MT-2990 in patients with AAV.
- Trial name
- NCT06196905
- Testing
- MT-2990
- Where
- 8 sites in Japan
- Volunteers
- 5 people
- Sponsor
- Tanabe Pharma Corporation
SLE, Sclerosis
A Study of RD06-04 in Patients With Active Autoimmune Diseases
This is an open-label, Phase I, investigator-initiated trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with autoimmune diseases mediated by…
- Conditions
- SLE, Sclerosis, ANCA Associated Vasculitis, IIM
- Trial name
- NCT06548620
- Testing
- RD06-04 cell infusion
- Where
- China
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis
Clinical Study on Targeted CD19CAR-T Therapy for Autoimmune Diseases
This is an open-label, investigator-initiated clinical trial (IIT) aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-04 in patients with active SLE, SSc, AAV, IIM, and pSS
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06549296
- Testing
- RD06-04 CART Cell Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
SLE, Systemic Sclerosis
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with active SLE, SSc, AAV, IIM, NMOSD, MS…
- Conditions
- SLE, Systemic Sclerosis, IIM, NMOSD
- Trial name
- NCT06775912
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Multiple Sclerosis, NMO Spectrum Disorder
Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
The RECLAIM study aims to gather a centralized and harmonized dataset, enabling the secondary use of data for building AI-based models that will support diagnosis and prognosis of individual Multiple Sclerosis patient's disease…
- Conditions
- Multiple Sclerosis, NMO Spectrum Disorder, Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease, Radiologically Isolated Syndrome
- Trial name
- RECLAIM (NCT06280755)
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 7,000 people, healthy volunteers welcome
- Sponsor
- icometrix
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
ANCA-associated Vasculitis
Efficacy and Safety of Substitution of Glucocorticoid for BDB-001 Injection in Patients With Anti-neutrophil Cytoplasmic Antibody(ANCA)-Associated Vasculitis
The aim of the trial is to study the efficacy and safety of treatment with BDB-001 Injection substitution of glucocorticoid in patients with ANCA-associated vasculitis.
- Trial name
- NCT05197842
- Testing
- BDB-001 injection, Cyclophosphamide, Glucocorticoids
- Where
- 22 sites in China
- Volunteers
- 93 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Antibody-mediated Rejection
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
- Trial name
- IMAGINE (NCT03744910)
- Testing
- Clazakizumab, Physiologic saline solution
- Where
- 142 sites in United States, Australia and 13 more
- Volunteers
- 194 people
- Sponsor
- CSL Behring
Relapsed/Refractory Autoimmune Diseases
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory autoimmune diseases.
- Trial name
- NCT06866080
- Testing
- LCAR-AIO T cells
- Where
- 4 sites in China
- Sponsor
- Nanjing Legend Biotech Co.
NSCLC Stage IV, KRAS Gene Mutation
Phase II Study of SHR-1210(Anti-PD-1 Antibody) Combination With Apatinib Versus Pemetrexed and Carboplatin in Subjects With KRAS Mutant Stage IV Non-squamous Non-small Cell Lung Cancer
This is a randomized, open-label, multi-center, phase II trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus Pemetrexed and Carboplatin in Subjects with KRAS mutant stage IV non-squamous Non-small…
- Conditions
- NSCLC Stage IV, KRAS Gene Mutation, PD-1 Antibody, Chemotherapy Effect
- Trial name
- NCT03777124
- Testing
- SHR-1210, Apatinib, Pemetrexed
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Antibody Typhoid Vaccine
Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV
Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential.
- Trial name
- NCT06921460
- Where
- Indonesia
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
ANCA-Associated Vasculitis
A Phase 3 Clinical Trial of CCX168 (Avacopan) in Patients With ANCA-Associated Vasculitis
The primary objective is to evaluate the efficacy of CCX168 (avacopan) to induce and sustain remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with…
- Trial name
- ADVOCATE (NCT02994927)
- Testing
- Avacopan, Prednisone, Cyclophosphamide
- Where
- 198 sites in United States, Australia and 18 more
- Volunteers
- 331 people
- Sponsor
- Amgen
ANCA-associated Vasculitis
Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
- Trial name
- NCT02222155
- Testing
- CCX168 10 mg, twice daily, plus cyclophosphamide/rituximab plus glucocorticoids, CCX168 30 mg, twice daily, cyclophosphamide/rituximab plus glucocorticoids
- Where
- 43 sites in United States, Canada
- Volunteers
- 42 people
- Sponsor
- Amgen
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study of NM8074 in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)
This is a Randomized, Double-Blind, Placebo-Controlled Study designed to assess safety, tolerability, and efficacy of NM8074 in AAV patients when used in combination with Standard of Care (SOC) cyclophosphamide/azathioprine or…
- Trial name
- NCT06226662
- Testing
- NM8074
- Volunteers
- 12 people
- Sponsor
- NovelMed Therapeutics
Renal Transplant Recipients With Anti-HLA Antibodies
A Prospective, Global, Multi-center, Treatment Registry Study of Intravenous Immunoglobulin Maintenance Therapy in Alloantibody Positive Renal Allograft Recipients
The purpose of this treatment registry study is to determine if monthly infusions of Intravenous Immunoglobulin (IVIg) for 6 months will neutralize donor specific antibodies that are thought to be responsible for chronic…
- Trial name
- DSA (NCT02115503)
- Where
- 8 sites in United States
- Volunteers
- 52 people
- Sponsor
- Databean
SLE (Systemic Lupus), Sjogren's Syndrome
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
This is a single arm study to evaluate the efficacy and safety of CD19 targeted CAR-T cells therapy for patients with Refractory Autoimmune Disease
- Conditions
- SLE (Systemic Lupus), Sjogren's Syndrome, Systemic Scleroderma, Dermatomyositis
- Trial name
- NCT06056921
- Testing
- CD19 targeted CAR-T cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Hepatic Impairment
A Study to Evaluate the Pharmacokinetics of Avacopan (CCX168) in Participants With Mild or Moderate Hepatic Impairment
The primary objective of this study will be to evaluate the pharmacokinetic properties of avacopan and its metabolite CCX168-M1 after a single oral dose of 30 mg avacopan in participants with mild or moderate hepatic impairment…
- Trial name
- NCT06004934
- Testing
- Avacopan
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amgen
Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
A Study in Healthy Volunteers to Evaluate the Drug-Drug Interaction Potential of CCX168 With Concomitant Medications
The primary objective of this study will be to evaluate the drug-drug interaction potential of CCX168 with concomitant medications, as either a perpetrator or a victim, following oral administration of CCX168 to healthy…
- Trial name
- NCT06004947
- Testing
- CCX168, Midazolam, Celecoxib
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen