Clinical trials: Sclerosis, Systemic
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
Sclerosis, Systemic
Clinical Cohort Study of Systemic Sclerosis
Systemic sclerosis (SSc) is an autoimmune disease primarily characterized by fibrosis of the skin and internal organs. In 2018, SSc was included in China's "First Batch of Rare Disease Catalog." Compared with the well-established…
- Trial name
- NCT07836361
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Peking University Third Hospital
Diffuse Cutaneous Systemic Sclerosis, Interstitial Lung Disease
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
- Trial name
- ATHENA-SSc-ILD (NCT05270668)
- Testing
- Tulisokibart, Companion diagnostic ( CDx)
- Where
- 95 sites in United States, Argentina and 18 more
- Volunteers
- 154 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
A Study of ATG-201 in Adult Participants With Autoimmune Diseases
This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Sjogren's Disease, Autoimmune Diseases
- Trial name
- ATTRACT (NCT07732309)
- Testing
- ATG-201
- Where
- 22 sites in China
- Volunteers
- 149 people
- Sponsor
- Antengene Biologics Limited
Systemic Sclerosis
A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
- Trial name
- Breakfree-SSc (NCT07335562)
- Testing
- BMS-986353, Fludarabine, Cyclophosphamide
- Where
- 56 sites in United States, Belgium and 8 more
- Volunteers
- 92 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Sclerosis in Adults
Rituximab vs Placebo for Maintenance in Systemic Sclerosis - Interstitial Lung Disease
The purpose of this study is to determine whether Rituximab is safe and effective as a maintenance strategy in individuals with stabilized systemic sclerosis in adults.
- Trial name
- MAINRITSyS (NCT07827742)
- Testing
- Rituximab
- Where
- France
- Volunteers
- 120 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Systemic Sclerosis, Dermatomyositis
Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study
Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare.
- Conditions
- Systemic Sclerosis, Dermatomyositis, iPPSD2
- Trial name
- ITS-PILOT (NCT03582800)
- Testing
- STS
- Where
- 11 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Limoges
Autoimmune Diseases, Ulcerative Colitis
A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease
The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation.
- Conditions
- Autoimmune Diseases, Ulcerative Colitis, Multiple Sclerosis, Scleroderma
- Trial name
- NCT06587828
- Testing
- Companion blood samples with procedure
- Where
- 11 sites in United States
- Volunteers
- 238 people
- Sponsor
- TScan Therapeutics, Inc.
Interstitial Lung Disease, Pulmonary Hypertension
Hyperpolarized Xenon MRI in Adults With Pulmonary Hypertension in Interstitial Lung Disease and Systemic Sclerosis
This study aims to evaluate a noninvasive magnetic resonance imaging technique using hyperpolarized xenon gas to measure lung function in adults with interstitial lung disease, pulmonary hypertension, and systemic sclerosis.
- Conditions
- Interstitial Lung Disease, Pulmonary Hypertension, Systemic Sclerosis
- Trial name
- NCT07821398
- Testing
- Hyperpolarized 129 Xenon Gas
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Bastiaan Driehuys
Scleroderma, Systemic, Digital Ulcer
Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis
This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers).
- Trial name
- NCT06256575
- Testing
- Diosmin
- Where
- 5 sites in Canada
- Volunteers
- 45 people
- Sponsor
- Primus Pharmaceuticals
Scleroderma, Systemic Sclerosis
Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1
Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients.
- Trial name
- SPIN-CLEAR #1 (NCT06373263)
- Testing
- Plain-language summary, Dissemination Tool (Infographic)
- Where
- Canada
- Volunteers
- 511 people
- Sponsor
- Lady Davis Institute
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal…
- Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy, Systemic Sclerosis
- Trial name
- RESOLUTION (NCT07085104)
- Testing
- ALLO-329, Cyclophosphamide, Fludarabine
- Where
- 17 sites in United States, Canada
- Volunteers
- 66 people
- Sponsor
- Allogene Therapeutics
Systemic Sclerosis Associated Interstitial Lung Disease, Scleroderma, Systemic
A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease
This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD).
- Trial name
- BLISSc-ILD (NCT05878717)
- Testing
- Belimumab
- Where
- 134 sites in United States, Argentina and 16 more
- Volunteers
- 300 people
- Sponsor
- GlaxoSmithKline
Systemic Sclerosis (SSc)
Clinical Study of CD19 CAR-T in the Treatment of Refractory Systemic Sclerosis
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-CD19 CAR-T cells in the treatment of childhood-onset systemic sclerosis
- Trial name
- NCT06792344
- Testing
- anti-CD19 CAR-T cells
- Where
- 2 sites in China, Christmas Island
- Volunteers
- 12 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
IgG4 Related Disease, Systemic Sclerosis (SSc)
Nebulized UC-EVs for Recurrent or Refractory IMIDs With Lung Involvement
Immune-mediated inflammatory diseases (IMIDs) are systemic inflammatory disorders driven by dysregulated immune responses that can affect multiple organs, including the lungs.
- Trial name
- NCT07806045
- Testing
- nebulized human umbilical cord mesenchymal stromal cell-derived extracellular vesicles
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Qiubai Li
Scleroderma, Diffuse, Scleroderma, Systemic
Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension
The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary…
- Conditions
- Scleroderma, Diffuse, Scleroderma, Systemic, Scleroderma, Limited, Sclerosis, Progressive Systemic
- Trial name
- NCT02682511
- Testing
- Oral Ifetroban
- Where
- 13 sites in United States, India
- Volunteers
- 34 people
- Sponsor
- Cumberland Pharmaceuticals