Clinical trials: Refractory Active Systemic Lupus Erythematosus
- Condition Refractory Active Systemic Lupus Erythematosus
- Funder type Industry (pharma, biotech, devices)
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
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
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.
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
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 Erthematosus (SLE)
KN5501 Cell Injection for Refractory SLE(CLEAR)
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE).
- Trial name
- CLEAR (NCT07358988)
- Testing
- KN5501 cell injection
- Where
- 6 sites in China
- Volunteers
- 36 people
- Sponsor
- Ruitherapeutics Co., LTD
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.
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 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
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
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
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
- 16 sites in United States, Brazil and 3 more
- Volunteers
- 35 people
- Sponsor
- Autolus Limited