Clinical trials: ANCA Associated Systemic Vasculitis
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
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 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
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
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
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
SLE - Systemic Lupus Erythematosus, Systemic Sclerosis
CD19/BCMA-Targeted Universal CAR-T Cell Injection for the Treatment of Autoimmune Diseases
This is a single-arm, open-label, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD06-05 in patients with autoantibody-mediated autoimmune…
- Conditions
- SLE - Systemic Lupus Erythematosus, Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07596680
- Testing
- RD06-05 CAR-T Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.
Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies
MTS109 in Patients With Refractory Autoimmune Diseases
This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathies, Systemic Sclerosis (SSc), ANCA-Associated Vasculitis (AAV)
- Trial name
- NCT07526350
- Testing
- MTS109
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Shanghai Changzheng Hospital
Inflammatory Rheumatism, Polymyalgia Rheumatica
PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy.
- Conditions
- Inflammatory Rheumatism, Polymyalgia Rheumatica, Giant Cell Arteritis, Idiopathic Inflammatory Myopathies
- Trial name
- PRODIGIOUS (NCT04664465)
- Where
- 12 sites in France
- Volunteers
- 300 people
- Sponsor
- University Hospital, Brest
Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis
Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases
- Conditions
- Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis, Refractory / Relapsing / Progressive Inflammatory Myopathy, Refractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
- Trial name
- NCT07490275
- Testing
- Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide, Fludarabine
- Volunteers
- 9 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Myocarditis, ANCA Associated Vasculitis
EACVI Study on Multimodality Cardiovascular Imaging of Inflammatory Cardiovascular Diseases
Inflammatory Cardiovascular Diseases and Autoimmune Rheumatic Diseases (ICARDs) encompass cardiovascular involvement in connective tissue diseases, vasculitis, and primary inflammatory cardiac processes affecting all layers of…
- Conditions
- Myocarditis, ANCA Associated Vasculitis, Pericarditis, Systemic Sclerosis
- Trial name
- EACVI-INFLAME (NCT07077304)
- Testing
- observational study
- Where
- France
- Volunteers
- 5,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM)
A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease
This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe…
- Conditions
- Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV), Idiopathic Inflammatory Myositis (IIM), Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06308978
- Testing
- FT819, Fludarabine, Cyclophosphamide
- Where
- 21 sites in United States, France and 2 more
- Volunteers
- 244 people
- Sponsor
- Fate Therapeutics
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07586267
- Testing
- QT-219CX
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Autoimmune Diseases, Systemic Lupus Erthematosus (SLE)
Allogeneic CD19/BCMA CAR-T for B Cell-Related Autoimmune Disease
This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C.
- Conditions
- Autoimmune Diseases, Systemic Lupus Erthematosus (SLE), Multi-Drug Resistant Nephrotic Syndrome, IgA Nephropathy (IgAN)
- Trial name
- NCT07507201
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 15 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Lupus Nephritis, Autoimmune Diseases
A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease.
- Conditions
- Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE)
- Trial name
- NCT06375993
- Testing
- ADI-001, Fludarabine, Cyclophosphamide
- Where
- 2 sites in United States
- Volunteers
- 180 people
- Sponsor
- Adicet Therapeutics
SLE (Systemic Lupus), Systemic Sclerosis
Clinical Study on Targeted CD19 or 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 CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV…
- Conditions
- SLE (Systemic Lupus), Systemic Sclerosis, ANCA Associated Vasculitis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06548607
- Testing
- CD19 or CD19-BCMA CAR-T
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Nanjing Bioheng Biotech Co., Ltd.