Clinical trials: Refractory Systemic Lupus Erythematosus, open to volunteers
Systemic Lupus Erythematosus, Active Refractory Rheumatoid Arthritis
A Phase 2 Master Protocol Assessing Inebilizumab and Blinatumomab in Autoimmune Diseases
The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and…
- Trial name
- NCT06570798
- Testing
- Inebilizumab, Blinatumomab
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 220 people
- Sponsor
- Amgen
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
Refractory Systemic Lupus Erythematosus
IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)
The study is a single-arm, open-label clinical trial intended to recruit 6 refractory SLE subjects who meet the inclusion and exclusion criteria.
- Trial name
- NCT06513429
- Testing
- IM19 CAR-T cells
- Where
- China
- Volunteers
- 6 people
- Sponsor
- Peking University Third Hospital
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
Refractory Autoimmune Diseases
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory…
- Trial name
- NCT07115745
- Testing
- BMS-986515, Fludarabine, Cyclophosphamide
- Where
- 28 sites in United States, Australia and 8 more
- Volunteers
- 125 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Refractory Systemic Lupus Erythematosus
CD19 CAR T-Cell Therapy for Refractory Systemic Lupus Erythematosus
The goal of this Phase I clinical trial is to evaluate the safety and tolerability of autologous CD19-targeted chimeric antigen receptor T-cell (CAR-T) therapy in adults with refractory systemic lupus erythematosus who have…
- Trial name
- NCT07432334
- Testing
- Autologous CD19-Targeted CAR-T Cells
- Where
- Vietnam
- Volunteers
- 8 people
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
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
Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis
Allogeneic CD19/BCMA-Targeted CAR-γδT Cell Therapy: Safety and Preliminary Pharmacodynamics in Relapsed/Refractory Autoimmune Diseases
This study is a single-arm, intervention, dose-escalation clinical trial to evaluate the safety of allogeneic CD19/BCMA-targeted CAR-γδT cell in the treatment of relapsed/refractory autoimmune diseases
- Conditions
- Refractory/Relapsed Systemic Lupus Erythematosus, Refractory / Relapsed / Progressive Systemic Sclerosis, Refractory / Relapsing / Progressive Inflammatory Myopathy, Refractory / Relapsed Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
- Trial name
- NCT07490275
- Testing
- Allogeneic CD19/BCMA-targeted CAR-γδT cell injection, Cyclophosphamide, Fludarabine
- Volunteers
- 9 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
IASO207 Injection for Active Refractory Systemic Lupus Erythematosus (SLE)
This is a single-center, open-label, exploratory clinical study designed to evaluate the efficacy and safety of IASO207 Injection (in vivo CAR-T) in patients with active refractory systemic lupus erythematosus.
- Trial name
- NCT07617740
- Testing
- IASO207 Injection
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Peking University People's Hospital
REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS, Lupus Nephritis
SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus
study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA.
- Trial name
- SELECT-SLE (NCT07523542)
- Testing
- Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells/kg)., Fludarabine, Cyclophosphamide
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Beijing Biotech
Systemic Lupus Erythematosus (SLE), Refractory
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the…
- Trial name
- NCT06892145
- Testing
- MC-1-50
- Where
- 2 sites in China
- Volunteers
- 12 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Refractory Active Systemic Lupus Erythematosus
A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and…
- Trial name
- NCT06694298
- Testing
- SYS6020
- Volunteers
- 50 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.