Clinical trials: Severe Systemic Sclerosis
Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
- Conditions
- Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia, Myasthenia Gravis, Systemic Sclerosis
- Trial name
- NCT06978738
- Testing
- universal allogeneic anti-CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Changzhou No.2 People's Hospital
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
Study Investigating the Safety of Anti-CD19 CAR-T Cells Therapy Produced at Gustave Roussy for Adults With Severe and Refractory Systemic Autoimmune Rheumatic Diseases
This is an open-label, single-dose, prospective, monocenter, Phase I interventional study (not first-in-human) to assess the safety, tolerability, and preliminary efficacy of autologous anti-CD19 CAR-T cells as an advanced…
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Sjogren's Disease With Dry Eyes, Systemic Sclerosis (SSc)
- Trial name
- CELL-ATTACK 1 (NCT07544225)
- Testing
- anti-CD19 CAR-T cells
- Where
- France
- Volunteers
- 6 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Multiple Sclerosis (MS), Myasthenia Gravis (MG)
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
This is an investigator-initiated, single-center, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard…
- Conditions
- Multiple Sclerosis (MS), Myasthenia Gravis (MG), Neuromyelitis Optica Spectrum Disorder, Systemic Lupus Erythematosus
- Trial name
- NCT07676266
- Testing
- CD20/BCMA-directed CAR-T cells Autologous 2nd generation
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The Affiliated Hospital of Qingdao University
Severe Systemic Sclerosis
Phase I/II Randomized Clinical Trial of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells Systemic Infusion in Severe Systemic Sclerosis
Systemic sclerosis (SSc) is a rare, severe and chronic systemic autoimmune disease (AD) characterized by vasculopathy, immune dysregulation and fibrosis leading to multi-organ dysfunction (primarily skin, lungs, heart…
- Trial name
- MSC-AT-SSc (NCT06722105)
- Testing
- 2 infusions of MSC, 1 infusion of MSC
- Volunteers
- 18 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Systemic Lupus Erythematosus, Systemic Sclerosis
Nonmyeloablative Allo Stem Cell Transplant for Severe Autoimmune Diseases
Autoimmune diseases present a special challenge to clinicians and the aim of this protocol is to serve as a last-line effort for patients with unmanageable disease.
- Trial name
- NCT00849745
- Testing
- Nonmyeloablative allogeneic stem cell transplant
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Duke University
Dry Eye, Sjogren's Syndrome
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye
Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort.
- Conditions
- Dry Eye, Sjogren's Syndrome, Graft vs. Host Disease
- Trial name
- NCT01393132
- Testing
- Thymosin Beta 4 eye drops, Vehicle Control
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Michigan Cornea Consultants, PC
Refractory Lupus Nephritis, Myasthaenia Gravis
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been…
- Conditions
- Refractory Lupus Nephritis, Myasthaenia Gravis, Stiff Person Syndrome, Rheumatoid Arthritis (RA)
- Trial name
- KYSA-4 (NCT07403188)
- Testing
- KYV-101
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Kyverna Therapeutics
CREST Syndrome, Peripheral Vascular Disease
Exparel as a Nerve Block for Severe Hand Pain
The purpose of this study is to investigate whether the use of the study drug (Exparel) is safe and effective for treating circulation problems and pain in the hand or fingers.
- Conditions
- CREST Syndrome, Peripheral Vascular Disease, Raynaud Disease, Scleroderma, Diffuse
- Trial name
- NCT02374320
- Testing
- liposomal bupivacaine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jose Soberon, MD
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)
A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)
- Trial name
- NCT06822881
- Testing
- CAR-T Therapy
- Where
- China
- Volunteers
- 27 people
- Sponsor
- Beijing GoBroad Hospital
Keratoconjunctivitis Sicca, Sjogren's Syndrome
Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome
A six-month clinical research trial to evaluate the effectiveness of an investigational medication for the treatment of dry eye syndrome in patients that have been diagnosed with moderate to severe dry eye syndrome, an autoimmune…
- Conditions
- Keratoconjunctivitis Sicca, Sjogren's Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
- Trial name
- NCT00025818
- Testing
- Ophthalmic Emulsion
- Where
- 17 sites in United States
- Volunteers
- 290 people
- Sponsor
- Allergan
Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN)
A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases
This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with B-cell-related…
- Conditions
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Multiple Sclerosis, Myasthenia Gravis (MG)
- Trial name
- ArchAid-002 (NCT07593911)
- Testing
- MTM-H-001 Injection
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Beijing GoBroad Hospital
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
Systemic Lupus Erythematosus, Sjögren's Disease
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
The purpose of this study is to evaluate the safety and tolerability of BMS-986553, CD19 in vivo Chimeric Antigen Receptor (CAR) T cells, in participants with refractory autoimmune diseases including systemic lupus erythematosus…
- Conditions
- Systemic Lupus Erythematosus, Sjögren's Disease, Rheumatoid Arthritis, Idiopathic Inflammatory Myopathies
- Trial name
- NCT07873931
- Testing
- BMS-986553
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 60 people
- Sponsor
- Bristol-Myers Squibb
Mesenchymal Stromal Cell, Systemic Sclerosis
Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis
Mesenchymal stromal cells (MSC) are multipotent cells which carry immunomodulatory, pro-angiogenic and anti-fibrotic properties, that can target Systemic Sclerosis (SSc) pathogenesis and its clinical manifestations.
- Trial name
- Pre_MSC-AT-SSc (NCT05947682)
- Testing
- Adipose tissue harvesting
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Moderate to Severe Systemic Sclerosis
A Phase 3 Study of KHK4827 in Patients With Systemic Sclerosis
To evaluate the efficacy and safety of KHK4827 in patients with systemic sclerosis who have moderate to severe skin thickening
- Trial name
- NCT03957681
- Testing
- KHK4827
- Where
- 6 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Systemic Sclerosis, Cardiac Diseases
Development and Prevention of Severe Heart Disease in Systemic Sclerosis
Systemic sclerosis is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Cardiac involvement, mainly characterised by small intramyocardial coronary artery involvement and…
- Conditions
- Systemic Sclerosis, Cardiac Diseases, Heart Block, Cardiac Arrhythmia
- Trial name
- NCT01829126
- Where
- 11 sites in France, Germany and 4 more
- Volunteers
- 765 people
- Sponsor
- Gabriele Valentini
Scleroderma, Diffuse
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis…
- Trial name
- NCT06655896
- Testing
- rapcabtagene autoleucel, rituximab
- Where
- 93 sites in United States, Argentina and 20 more
- Volunteers
- 96 people
- Sponsor
- Novartis Pharmaceuticals
Scleroderma, Systemic, Sclerosis
Scleroderma: Cyclophosphamide or Transplantation
SCOT is a clinical research study designed for people with severe forms of scleroderma. SCOT stands for Scleroderma: Cyclophosphamide Or Transplantation.
- Conditions
- Scleroderma, Systemic, Sclerosis, Autoimmune Disease
- Trial name
- SCOT (NCT00114530)
- Testing
- mHSCT, cyclophosphamide
- Where
- 17 sites in United States, Canada
- Volunteers
- 75 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Systemic Scleroderma
Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis
The purpose of the study is to see how well reduced intensity conditioning followed by a stem cell transplant from a donor (allogeneic) works in treating patients with severe systemic sclerosis.
- Trial name
- NCT01047072
- Testing
- fludarabine phosphate, total-body irradiation, tacrolimus
- Where
- United States
- Sponsor
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Systemic Sclerosis (SSc)
Clinical Study on the Treatment of Systemic Sclerosis With UTAA91 Injection.
This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase study, with the primary objective of evaluating the safety of UTAA91 injection in subjects with refractory…
- Trial name
- NCT06982534
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 24 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.