Clinical trials: Refractory SLE
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, 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.
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
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
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.
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.
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), 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
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
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
Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV
AB-101 in Combination With B-Cell Depleting mAb in Patients Who Failed Treatment for Class III or IV Lupus Nephritis or Other Forms of Refractory Systemic Lupus Erythematosus
AB-101 (also known as AlloNK) is an off-the shelf, allogeneic cell product made of "natural killer" cells, also called NK cells.
- Conditions
- Lupus Nephritis - WHO Class III, Lupus Nephritis - WHO Class IV, Refractory Systemic Lupus Erythematosus, SLE
- Trial name
- NCT06265220
- Testing
- AB-101, Cyclophosphamide, Fludarabine
- Where
- 9 sites in United States
- Volunteers
- 51 people
- Sponsor
- Artiva Biotherapeutics, Inc.
Systemic Lupus Erythematosus
Clinical Study of ZM001 Injection in the Treatment of Refractory Systemic Lupus Erythematosus
This is an open, single-arm, phase I clinical study of ZM001 in patients with refractory systemic lupus erythematosus
- Trial name
- NCT06852573
- Testing
- ZM001 Injection
- Volunteers
- 18 people
- Sponsor
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Systemic Lupus Erythematosus
Study of Ultra-Fast BCMA/CD70 CAR-T Therapy for Refractory SLE
This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous BCMA/CD70-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.
- Trial name
- NCT07318259
- Testing
- BCMA/CD70 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd