Clinical trials: Refractory Active Systemic Lupus Erythematosus
Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV)
IMPT-514 in Systemic Lupus Erythematosus, Anca-associated Vasculitis, and Idiopathic Inflammatory Myopathy
This is an exploratory trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of a single dose of IMPT-514, an autologous, anti-CD19/CD20 CAR T therapy, administered as an intravenous (IV)…
- Conditions
- Systemic Lupus Erythematosus (SLE), ANCA Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathy (IIM)
- Trial name
- NCT06462144
- Testing
- IMPT-514 CART Cell Injection
- Where
- 3 sites in China
- Volunteers
- 3 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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
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
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus
This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or…
- Trial name
- DISCOVERY (NCT07881120)
- Testing
- Afimetoran
- Where
- 3 sites in United States
- Volunteers
- 390 people
- Sponsor
- Beeline Medicines Corporation
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.
Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with cutaneous lupus erythematosus (CLE).
- Trial name
- AMETHYST (NCT05531565)
- Testing
- Litifilimab
- Where
- 315 sites in United States, Argentina and 28 more
- Volunteers
- 450 people
- Sponsor
- Biogen
Systemic Lupus Erythematosus, Lupus Nephritis
UB-VV410 in Subjects With Active Refractory Systemic Lupus Erythematosus or Lupus Nephritis
This is an open-label investigator-initiated trial (IIT) to assess the safety, efficacy, and PK（pharmacokinetic）/PD（pharmacodynamics ） of UB-VV410 in adult subjects with clinically active treatment-refractory SLE.
- Trial name
- NCT07109986
- Testing
- UB-VV410
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Nanjing IASO Biotechnology Co., Ltd.
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
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 Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
This is a Phase 1/2, multi-center, open-label study evaluating the safety and efficacy of IMPT-514, a bispecific chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 and CD20 in participants with active…
- Trial name
- NCT06153095
- Testing
- IMPT-514
- Where
- 4 sites in United States, Australia
- Sponsor
- Lyell Immunopharma, Inc.
Systemic Lupus Erythematosus (SLE)
An Open-label Study of GB261 in Refractory Seropositive Systemic Lupus Erythematosus
The purpose of the study is to evaluate the safety and efficacy of CD20xCD3 T-cell engager (GB261) in patients with refractory seropositive systemic lupus erythematosus.
- Trial name
- NCT06945068
- Testing
- GB261
- Where
- China
- Volunteers
- 19 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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
Systemic Lupus Erythematosus
Clinical Study of A-319 in the Treatment of Active/Refractory Systemic Lupus Erythematosus
The purpose of the study is to explore the safety and efficacy of recombinant CD19xCD3 double antibody (A-319) in active/refractory systemic lupus erythematosus (SLE).
- Trial name
- NCT06400537
- Testing
- A-319
- Where
- 2 sites in China
- Volunteers
- 25 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
Lupus Nephritis
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and…
- Trial name
- LUMINA (NCT07053800)
- Testing
- Obecabtagene autoleucel
- Where
- 15 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited
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
System Lupus Erythematosus(SLE)
Study of YKST02 Alone or in Combination With YK012 in Patients With Active or Refractory Systemic Lupus Erythematosus
The purpose of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of YKST02 administered alone or in combination with YK012 in…
- Trial name
- NCT07512947
- Testing
- YKST02, YK012
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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
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