Clinical trials: ANCA Associated Vasculitis, active
Takayasu's Arteritis, Giant Cell Arteritis
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Background: Vasculitis is a group of diseases that inflame and damage blood vessels and tissue. It can cause many medical problems. Few tests can diagnose the disease, and none can reliably predict a relapse.
- Conditions
- Takayasu's Arteritis, Giant Cell Arteritis, Polyarteritis Nodosa, Relapsing Polychondritis
- Trial name
- NCT02257866
- Where
- United States
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
Anti-Neutrophil Cytoplasm Antibodies (ANCA) Associated Vasculitis
Iptacopan in Patients With ANCA Associated Vasculitis
The purpose of this study is to evaluate the efficacy and safety of iptacopan compared to standard of care (SOC) to induce and maintain remission in study participants with active granulomatosis with polyangiitis (GPA) or…
- Trial name
- NCT06388941
- Testing
- Iptacopan, Rituximab
- Where
- 40 sites in United States, Argentina and 13 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
ANCA Associated Vasculitis (AAV)
Qualitative Study With Focus Groups of People Living With ANCA-associated Vasculitis (AAV) and Clinicians, to Explore Different Perspectives on Shared Decision-making in AAV.
This research aims to underpin qualitative work with people living with a diagnosis of AAV and healthcare professionals working with people living with AAV, to explore different perspectives on Shared Decision Making (SDM) in…
- Trial name
- PACT-AAV (NCT07859995)
- Where
- United Kingdom
- Volunteers
- 80 people
- Sponsor
- University of the West of England
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined With Immunosuppressants in the Treatment of Refractory Autoimmune Diseases
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage.
- Conditions
- Systemic Lupus Erthematosus, Systemic Sclerosis (SSc), Inflammatory Myopathies, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06821659
- Testing
- anti-CD19 CAR-T cells
- Volunteers
- 9 people
- Sponsor
- Peking University Third Hospital
System Lupus Erythematosus, Systemic Sclerosis (SSc)
Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases
This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its…
- Conditions
- System Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myositis, Antiphospholipid Syndrome
- Trial name
- NCT07301164
- Testing
- BCT301
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Peking University Third Hospital
Systemic Lupus Erthematosus, Systemic Sclerosis (SSc)
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage.
- Conditions
- Systemic Lupus Erthematosus, Systemic Sclerosis (SSc), Sjogren Syndrome, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT06828042
- Testing
- anti-CD19 CAR T cell therapy
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Peking University Third Hospital
Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101
The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases.
- Conditions
- Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis, SLE Nephritis, ANCA Associated Vasculitis
- Trial name
- CARTIMMUNE (NCT06152172)
- Testing
- KYV-101, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- David Porter
Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases
the Safety and Efficacy of Targeted BCMA In Vivo LV Injection for Recurrent or Refractory Autoimmune Diseases
This study is designed as a single arm, open label, single center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetic or pharmacodynamic characteristics of the investigational drug V001-BCMA in…
- Conditions
- Recurrent or Refractory Systemic Lupus Erythematosus, Recurrent or Refractory IgG4 Related Diseases, Recurrent or Refractory Systemic Sclerosis, Recurrent or Refractory Idiopathic Inflammatory Myopathy
- Trial name
- NCT07339540
- Testing
- V001-BCMA
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Tongji Hospital
ANCA-Associated Glomerulonephritis (AAGN), ANCA-Associated Vasculitis (AAV)
Obinutuzumab Beta Combined With Low-dose Glucocorticoid in New-onset ANCA-Associated Glomerulonephritis
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated…
- Trial name
- NCT07746180
- Testing
- Obinutuzumab beta, Glucocorticoids
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Chinese PLA General Hospital
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
ANCA Associated Vasculitis (AAV)
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)
- Trial name
- NCT06868290
- Testing
- Rapcabtagene autoleucel, Active Comparator, Glucocorticoids
- Where
- 39 sites in United States, Brazil and 6 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
FT839 in Autoimmune Diseases
The primary objectives of this trial are to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose of FT839 with or without rituximab and/or background therapy and/or…
- Conditions
- ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT07800871
- Testing
- FT839
- Where
- United States
- Volunteers
- 446 people
- Sponsor
- Fate Therapeutics
ANCA Associated Vasculitis, Cardiovascular Diseases
ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)
ANCA-associated vasculitis is an autoimmune disease that causes damage to blood vessels. This leads to organ damage with the number of organs affected and the severity of damage varying significantly between patients.
- Conditions
- ANCA Associated Vasculitis, Cardiovascular Diseases, Kidney Diseases
- Trial name
- SPARVASC (NCT05630612)
- Testing
- Sparsentan
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- University of Edinburgh
Systemic Lupus Erythematosus, Systemic Scleroderma
Characterization of Autoreactive b Lymphocytes in Autoimmune Diseases and Immune Deficiencies
Autoimmune diseases (AID), whether systemic or organ-specific, affect approximately one in ten people, and their prevalence continues to increase.
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma, ANCA-associated Vasculitis, Antiphospholipid Syndrome
- Trial name
- AutoB-Tetramer (NCT07251179)
- Testing
- blood draw
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Strasbourg, France
ANCA Associated Vasculitis (AAV)
BDB-001 Phase III Trial in ANCA-Associated Vasculitis
The primary aim is to study the efficacy of treatment with BDB-001 Injection to induce remission in patients with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), when used in combination with…
- Trial name
- NCT07168161
- Testing
- BDB-001 injection, Cyclophosphamide, Rituximab
- Where
- 65 sites in China
- Volunteers
- 300 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Pericarditis, Tako-TSUBO Cardiomyopathy
Inflammatory Disease Biobank for Immunophenotyping and Cardiovascular Research
INFLAME-BANK is a French multicenter prospective observational ancillary study of the international EACVI-INFLAME project. It aims to establish a biobank and perform immunophenotyping and proteomic analyses in patients with…
- Conditions
- Pericarditis, Tako-TSUBO Cardiomyopathy, Myocarditis, Inflammatory Cardiomyopathies
- Trial name
- INFLAME-BANK (NCT07737470)
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
SLE, LN
A Study of Anti-CD19/BCMA Universal CAR-T Cell Therapy RD06-05 in Patients With Autoimmune Diseases.
An Exploratory, Single-Arm, Open-Label, Dose-Escalation Study of the Safety, Tolerability, PK, PD, and Efficacy of Anti-CD19/BCMA Universal CAR-T Therapy RD06-05 in Autoimmune Diseases (including SLE/LN, AAV/AAGN, Anti-GBM, MN…
- Conditions
- SLE, LN, ANCA Associated Vasculitis, ANCA-Associated Glomerulonephritis
- Trial name
- NCT07203404
- Testing
- RD06-05 CART Cell Injection
- Where
- China
- Volunteers
- 96 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV)
Descartes-08 for Children, Adolescents, and Young Adults With Autoimmune Disorders
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
- Conditions
- Childhood-onset Systemic Lupus Erythematous, ANCA-Associated Vasculitis (AAV), Juvenile Myasthenia Gravis, Juvenile Dermatomyositis
- Trial name
- NCT07089121
- Testing
- Descartes-08
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cartesian Therapeutics
ANCA-associated Vasculitis
Avacostar - (PASS)
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second cohort treated with a…
- Trial name
- Avacostar (NCT05897684)
- Where
- 35 sites in Germany, United Kingdom
- Volunteers
- 507 people
- Sponsor
- Vifor Fresenius Medical Care Renal Pharma