Clinical trials: Refractory Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics…
- Trial name
- CARLYSLE (NCT06333483)
- Testing
- Obecabtagene autoleucel (obe-cel)
- Where
- 6 sites in Spain, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Autolus Limited
Systemic Lupus Erythematosus (SLE)
A Clinical Study of Dual-Target, Universal CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
This study is a single-arm, open-label clinical study designed to evaluate the safety and tolerability of QT-019B in subjects with refractory SLE and to determine the RD.
- Trial name
- NCT07444307
- Testing
- QT-019B Cell Injection
- Where
- 3 sites in China
- Volunteers
- 18 people
- Sponsor
- Hangzhou Qihan Biotech Co., Ltd.
Systemic Lupus Erythematosus, Systemic Sclerosis
An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis, Inflammatory Myopathy, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06379646
- Testing
- YTS109
- Where
- China
- Volunteers
- 6 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Lupus Erythematosis
F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus
This is a phase I clinical study to evaluate the safety , pharmacokinetic profile, and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus.
- Trial name
- NCT06468683
- Testing
- After preconditioning with chemotherapy, F01 will be evaluated.
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Simnova Biotechnology Co.,Ltd.
Systemic Lupus Erythematosus
Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07233642
- Testing
- CD19 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
Autoimmune Diseases
CAR-T Cells Therapy for Patients With Autoimmune Diseases
This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
- Trial name
- ECAR01 (NCT07052565)
- Testing
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Anhui Provincial Hospital
System Lupus Erythematosus(SLE), Scleroderma
Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases
A FIH, single arm, open-label, Investigator Initiated Trial (IIT) study to evaluate the safety and tolerability of EVM18001 in the treatment of active refractory autoimmune diseases (SLE, MG, and SSc), and determine the…
- Conditions
- System Lupus Erythematosus(SLE), Scleroderma, Myasthenia Gravis (MG)
- Trial name
- NCT07470151
- Testing
- EVM18001 Injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Systemic Lupus Erythematosus, Rheumatoid Arthritis
Early Clinical Study of UTAA91 Injection for the Treatment of Relapsed/Refractory Autoimmune Diseases
This clinical trial is designed as a single - arm, open - label, single - center, investigator - initiated early - phase clinical study.
- Conditions
- Systemic Lupus Erythematosus, Rheumatoid Arthritis, Dry Syndrome, Idiopathic Inflammatory Myopathies
- Trial name
- NCT06970951
- Testing
- UTAA91 injection
- Where
- China
- Volunteers
- 15 people
- Sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Rheumatoid Arthritis, Dermatomyositis
Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases.
- Conditions
- Rheumatoid Arthritis, Dermatomyositis, Systemic Lupus Erythematosus, Systemic Sclerosis
- Trial name
- NCT07558850
- Testing
- anti-CD19/BCMA-UCAR-T cells
- Where
- China
- Volunteers
- 72 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Systemic Lupus Erythematosus, Lupus Nephritis
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- BAH242 (NCT06350110)
- Testing
- CD19- BCMA CAR-T cells
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Essen Biotech
Systemic Lupus Erythematosus, Autoimmune Diseases
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Systemic Lupus Erythematosus
- Trial name
- NCT05030779
- Testing
- Assigned Interventions CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Zhejiang University
Systemic Lupus Erythematosus, Systemic Sclerosis (SSc)
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Inflammatory Myopathy, ANCA-Associated Vasculitis (AAV)
- Trial name
- NCT06941129
- Testing
- UCAR T-cell
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Refractory Systemic Lupus Erythematosus, Refractory Lupus Nephritis
NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus/Lupus Nephritis
This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus…
- Trial name
- NCT06676631
- Testing
- NK 010 or NK042, Rituximab
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Guangdong Provincial People's Hospital
Systemic Lupus Erythematosus, Systemic Sclerosis
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.
- Trial name
- NCT07155369
- Testing
- UCAR-T cells, Cyclophosphamide, Fludarabine
- Where
- China
- Volunteers
- 18 people
- Sponsor
- The Affiliated Hospital of Xuzhou Medical University
Lupus Nephritis
Iguratimod as Treatment for Refractory Lupus Nephritis
This study is to evaluate the efficacy and safety of a novel chemical synthetic agent iguratimod as treatment of refractory lupus nephritis.
- Trial name
- NCT03054545
- Testing
- Iguratimod
- Where
- China
- Volunteers
- 30 people
- Sponsor
- RenJi Hospital
Lupus Erythematosus, Systemic, System; Sclerosis
Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases
The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM/PM, and AAV.
- Conditions
- Lupus Erythematosus, Systemic, System; Sclerosis, ANCA Associated Vasculitis, Dermatomyositis
- Trial name
- CATARSIS (NCT06685042)
- Testing
- CAR T cell
- Where
- Italy
- Volunteers
- 8 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lupus Erythematosus, Systemic, Lupus Nephritis
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active…
- Trial name
- NCT06581198
- Testing
- rapcabtagene autoleucel
- Where
- 107 sites in United States, Argentina and 24 more
- Volunteers
- 179 people
- Sponsor
- Novartis Pharmaceuticals
SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
CAR T-cell Therapy Targeting CD19 and BCMA(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
- Conditions
- SLE - Systemic Lupus Erythematosus, SSc-Systemic Sclerosis, IIM- Idiopathic Inflammatory Myopathies, ANCA Associated Vasculitis (AAV)
- Trial name
- NCT07315087
- Testing
- QT-019C
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Systemic Lupus Erythematosus, Lupus Nephritis
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease
This is a phase 1 study of SYNCAR-001 + STK-009 in patients with severe, refractory systemic autoimmune rheumatic disease.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis
- Trial name
- NCT06544330
- Testing
- SYNCAR-001, STK-009
- Where
- 6 sites in United States
- Volunteers
- 48 people
- Sponsor
- Synthekine
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd