Clinical trials: SLE (Systemic Lupus)
SLE - Systemic Lupus Erythematosus
Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
Systemic lupus erythematosus (SLE) is a complex autoimmune disorder that affects individuals globally, yet there is a significant lack of data regarding its prevalence and management, particularly in Asian populations like…
- Trial name
- PAN-SLE (NCT07902622)
- Testing
- no active ingredient
- Where
- Pakistan
- Volunteers
- 3,000 people
- Sponsor
- Foundation University Islamabad
Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE)
C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Lupus Nephritis Refractory to Standard Therapy
This Phase 2, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20/BCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in…
- Conditions
- Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE), Autoimmune Diseases
- Trial name
- NCT07729826
- Testing
- C-CAR168
- Volunteers
- 50 people
- Sponsor
- AbelZeta Inc.
Childhood-Onset Systemic Lupus Erythematosus, Refractory SLE
CD19 CAR-T Therapy for Refractory Childhood-Onset Systemic Lupus Erythematosus
This study is evaluating the safety and potential benefits of CD19 chimeric antigen receptor T-cell (CAR-T) therapy in children and young adults with severe systemic lupus erythematosus (SLE) that began during childhood.
- Conditions
- Childhood-Onset Systemic Lupus Erythematosus, Refractory SLE, CD19 CAR-T Cell Therapy
- Trial name
- NCT07855302
- Testing
- SNUH-CD19-CAR-T Cells, Lymphodepleting Chemotherapy
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Seoul National University Hospital
SLE, Systemic Lupus Erythematosus (SLE)
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients…
- Conditions
- SLE, Systemic Lupus Erythematosus (SLE), CAR T Cell, CART19
- Trial name
- NCT06839976
- Testing
- CART19
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Children's Hospital of Philadelphia
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single…
- Trial name
- NCT07328581
- Testing
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- iCell Gene Therapeutics
Lupus Nephritis, Systemic Lupus Erythematosus
A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis
The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, SLE - Systemic Lupus Erythematosus, Lupus Nephritis - WHO Class III
- Trial name
- RECLAIM-LN (NCT07570862)
- Testing
- FT819
- Where
- 12 sites in United States
- Volunteers
- 53 people
- Sponsor
- Fate Therapeutics
Systemic Lupus Erythematosus (SLE)
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response…
- Trial name
- BENCHMARK-SLE (NCT07175285)
- Testing
- Current standard of care treatment options
- Where
- 66 sites in United States, Argentina and 11 more
- Volunteers
- 223 people
- Sponsor
- Bristol-Myers Squibb
Systemic Lupus Erthematosus (SLE)
Team-based Implementation of Hypertension Management in Childhood Lupus
The goal of this study is to compare the effectiveness of widely used implementation strategies to promote adherence to guideline-concordant evidence-based practices for monitoring and controlling blood pressure in patients with…
- Trial name
- ABOUT TIME (NCT07792733)
- Testing
- Health Navigator Engagement, Team Charter with Performance Monitoring, Pre-visit worksheet
- Volunteers
- 1,200 people
- Sponsor
- Boston Children's Hospital
Rheumatic Diseases, Arthritis
Pain-Sleep in Rheumatic Disease
Overall, our understanding of how pain and sleep are experienced and how they can be treated in teenagers with rheumatic diseases is limited.
- Conditions
- Rheumatic Diseases, Arthritis, Lupus, Lupus Arthritis, Systemic Lupus Erythematosus
- Trial name
- NCT07775612
- Testing
- Better Nights, Better Days for Youth
- Volunteers
- 43 people
- Sponsor
- The Hospital for Sick Children
Lupus Nephritis, Systemic Lupus Erythematosus (SLE)
Assessing Residual Inflammation and Macrophage Presence in Lupus Nephritis After 3 Months of Intensified Treatment With Prednisolone, Mycofenolate Mofetil and Voclosporin as Compared to Mycofenolate Mofetil and Prednisolone
The goal of this clinical trial is to learn how different treatments affect immune cells in the kidney in people with active lupus nephritis (LN), a kidney manifestation of systemic lupus erythematosus (SLE).
- Trial name
- MAPLE (NCT07760480)
- Testing
- Kidney Biopsy, Voclosporin (LUPKYNIS), Blood, feces and urine sample collection
- Where
- Netherlands
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE)
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Autoimmune Disease
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory autoimmune disease, however not all disease responds or remains in response to CD19 targeted CAR-T cells.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erthematosus (SLE), Dermatomyositis (DM), Systemic Sclerosis (SSc)
- Trial name
- NCT07729995
- Testing
- LMY-922
- Where
- United States
- Volunteers
- 94 people
- Sponsor
- Luminary Therapeutics
Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA)
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune…
- Conditions
- Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Systemic Lupus Erythematosus (SLE), Juvenile Systemic Lupus Erythematosus
- Trial name
- BTNDV-ARD (NCT07087912)
- Testing
- Dengue 1,2,3,4 (attenuated) vaccine
- Where
- 2 sites in Brazil
- Volunteers
- 477 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Immune Thrombocytopenic Purpura ( ITP ), Systemic Lupus Erythematosus (SLE)
Modeling the Early Stages of Autoimmunity Through the Study of Immunological Thrombocytopenic Purpura and Juvenile Lupus
Immunologic thrombocytopenic purpura (ITP) in children is a pre-lupus condition if associated with the presence of anti-nuclear antibodies (ANA), providing a unique model for understanding the natural history of autoimmunity…
- Trial name
- PRELUDE (NCT07680010)
- Testing
- Blood sampling baseline and M3, Monitoring for SLE, Procedure/Surgery: Blood sampling baseline and M3 then each 6 months until 48 months
- Where
- 2 sites in France
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- University Hospital, Bordeaux
Systemic Lupus Erythematosus (SLE), Visual Function
Study on Early Visual Dysfunction in Patients With Systemic Lupus Erythematosus
OCT, OCTA, fundus photography, and fundus autofluorescence ( FAF ) were used to observe the fundus physiological indexes of normal subjects and SLE patients, to explore the differences of subclinical retinal damage in SLE…
- Trial name
- NCT07679776
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- The First Affiliated Hospital of Anhui Medical University
Autoimmune Diseases, SLE - Systemic Lupus Erythematosus
RD06-05 Universal CD19/BCMA CAR-T for Refractory Pediatric Autoimmune Diseases
This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19/BCMA dual-targeting chimeric antigen receptor T-cell…
- Conditions
- Autoimmune Diseases, SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies
- Trial name
- NCT07674147
- Testing
- RD06-05 CART Cell Infusion
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Lupus, Dermatomyositis, Juvenile
Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress
The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents…
- Conditions
- Lupus, Dermatomyositis, Juvenile, Dermatomyositis, Lupus Erythematosus
- Trial name
- TEAM-LEADS (NCT06999109)
- Testing
- TEAM-LEADS
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Duke University
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
Systemic Lupus Erythematosus (SLE)
Mediterranean Diet and Gut Microbiota in Children With Systemic Lupus Erythematosus
The goal of this clinical trial is to learn if a Mediterranean diet can improve gut microbiota, disease activity, and nutrition in children with systemic lupus erythematosus (SLE).
- Trial name
- NCT07555626
- Testing
- Mediterranean Diet-Based Individual Nutrition Counseling
- Where
- Turkey (Türkiye)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- TC Erciyes University