Clinical trials: REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
Systemic Lupus Erythematosus, Inflammatory Myopathy
BCMA-CD19 CAR-T Therapy for Refractory Autoimmune Diseases
The objective of this study is to evaluate the efficacy and safety of BCMA/CD19 chimeric antigen receptor (CAR)-modified T cells in the treatment of autoimmune diseases.
- Conditions
- Systemic Lupus Erythematosus, Inflammatory Myopathy, Systemic Sclerosis (SSc), ANCA-associated Vasculitis
- Trial name
- NCT06794008
- Testing
- BCMA-CD19 CAR-T therapy
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University People's Hospital
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases
CALiPSO-1 is a Phase 1, multi-centre, dose-confirmation study to evaluate the safety and efficacy of CNTY-101 in participants with refractory B cell-mediated autoimmune diseases including those with moderate to severe systemic…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Idiopathic Inflammatory Myopathies, Diffuse Cutaneous Systemic Sclerosis
- Trial name
- CALiPSO-1 (NCT06255028)
- Testing
- CNTY-101, IL-2, Lymphodepleting Chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Century Therapeutics, Inc.
Difficult to Treat Systemic Lupus Erythematosus
Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is an open label, single arm exploratory clinical trial of IC19 CAR-T cell therapy for refractory systemic lupus erythematosus.
- Trial name
- IC19 CAR-T (NCT06886919)
- Testing
- Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
- Volunteers
- 6 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Systemic Lupus Erythematosus
Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus
This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been…
- Trial name
- NCT01741857
- Testing
- human umbilical cord derived MSC transplantation for SLE
- Where
- China
- Volunteers
- 40 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST LTE (NCT06044337)
- Testing
- BIIB059 (litifilimab)
- Where
- 104 sites in United States, Argentina and 23 more
- Volunteers
- 306 people
- Sponsor
- Biogen
Lupus Erythematosus, Graft-versus-host Disease
Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)
The main goal of the study is to determine if bone marrow transplant (BMT) from a less specific pool of donors in combination with high dose cyclophosphamide can induce remission of refractory systemic lupus erythematosus.
- Trial name
- NCT02080195
- Testing
- Cyclophosphamide, Fludarabine, Tacrolimus
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Autoimmune Thrombocytopenia
Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia
This is a single-arm, open-label，phase I clinical study to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection in treatment of refractory systemic lupus erythematosus-related immune thrombocytopenia.
- Trial name
- NCT06826430
- Testing
- Inaticabtagene autoleucel Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE), Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD)
A Clinical Study to Evaluate LVIVO-TaVec400 for the Treatment of Relapsed/Refractory Autoimmune Diseases
This is a prospective, single-arm, open-label dose-escalation clinical study to evaluate LVIVO-TaVec400 in the treatment of relapsed/refractory autoimmune diseases.
- Conditions
- Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE), Relapsed/Refractory IgG4-Related Disease (r/r IgG4-RD), Progressive Multiple Sclerosis (PMS), Relapsed/Refractory Myasthenia Gravis(r/r MS)
- Trial name
- NCT07583030
- Testing
- LVIVO-TaVec400 product
- Where
- 4 sites in China
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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, Idiopathic Inflammatory Myopathy
A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).
- Conditions
- Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
- Trial name
- NCT05869955
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 46 sites in United States, Belgium and 4 more
- Volunteers
- 270 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Systemic Lupus Erythematosus (SLE), Children
Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults. It will also learn about the safety of blinatumomab.
- Conditions
- Systemic Lupus Erythematosus (SLE), Children, Blinatumomab
- Trial name
- BRASLE (NCT06789107)
- Testing
- Blinatumomab 9ug
- Where
- 2 sites in China
- Volunteers
- 6 people
- Sponsor
- Mao Jianhua
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc)
A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases
This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06978647
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Systemic Lupus Erythematosus
Alnuctamab for Refractory SLE (LATTE Study)
This study will assess the safety and preliminary efficacy of the bi-specific TCE, alnuctamab (known as BMS-986349, CC-93269, EM901), targeting BCMA in patients with moderate to severe SLE, refractory to standard-of-care…
- Trial name
- NCT07219563
- Testing
- Alnuctamab
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Refractory Active Systemic Lupus Erythematosus
A Clinical Study of ACG102 Injection in Patients With Refractory Active Systemic Lupus Erythematosus
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of ACG102 administered via intravenous injection in patients with…
- Trial name
- NCT07749430
- Testing
- ACG102 Injection
- Volunteers
- 13 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Systemic Lupus Erythematosus
Study of CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07403097
- Testing
- PTOC1
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Systemic Lupus Erythematosus (SLE)
Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.
- Trial name
- NCT05988216
- Testing
- BRL-301
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Bioray Laboratories
CAR-T
Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus
This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.
- Trial name
- NCT05846347
- Testing
- GC012F injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Zhejiang University
Systemic Lupus Erythematosus (SLE)
Early Myocardial Dysfunction Helps Identify Severe Refractory Pediatric Lupus
To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.
- Trial name
- NCT07425730
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Lupus Nephritis
CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis
A Clinical Study of the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Refractory/Relapsed Lupus Nephritis.
- Trial name
- NCT06785519
- Testing
- CD19/BCMA Lupus Nephritis Targeted CAR T-cells injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- He Huang
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