Clinical trials: REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS
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
Refractory Lupus Nephritis, Myasthaenia Gravis
A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101
The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been…
- Conditions
- Refractory Lupus Nephritis, Myasthaenia Gravis, Stiff Person Syndrome, Rheumatoid Arthritis (RA)
- Trial name
- KYSA-4 (NCT07403188)
- Testing
- KYV-101
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Kyverna 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
Lupus Nephritis, Systemic Lupus Erythematosus
US Zamto-cel Autoimmune Diseases
AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard…
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
- Trial name
- NCT06708845
- Testing
- zamtocabtagene autoleucel, Cyclophosphamide, Fludarabine
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Miltenyi Biomedicine GmbH
Systemic Lupus Erythematosus, Lupus Nephritis
A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in…
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy
- Trial name
- NCT07038447
- Testing
- KITE-363, Fludarabine, Cyclophosphamide
- Where
- 10 sites in United States, Australia and 2 more
- Volunteers
- 52 people
- Sponsor
- Kite, A Gilead Company
Lupus Erythematosus, Systemic Lupus Erythematosus
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
SC291-102 is a Phase 1 study to evaluate SC291 safety and tolerability, preliminary clinical response, cellular kinetics and exploratory assessments for subjects with severe autoimmune diseases.
- Conditions
- Lupus Erythematosus, Systemic Lupus Erythematosus, SLE (Systemic Lupus), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Trial name
- NCT06294236
- Testing
- SC291
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Sana Biotechnology
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.
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
- NCT07331467
- Testing
- CD19 CAR-T cells
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Chongqing Precision Biotech Co., Ltd
Inflammatory Diseases
Study of Efavaleukin Alfa in Healthy Chinese, Japanese, and Caucasian Participants
The primary objective of this study is to evaluate the pharmacokinetics (PK) of efavaleukin alfa after single subcutaneous (SC) administration in healthy Chinese, Japanese, and Caucasian participants.
- Trial name
- NCT04987333
- Testing
- Efavaleukin alfa
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Amgen
Lupus Nephritis (LN)
C-CAR168 CAR T Cell Therapy for Refractory Autoimmune Disease
This multi-center, open-label, Phase 1/2 study aims to evaluate the safety, tolerability, and preliminary efficacy of C-CAR168, an autologous anti-CD20/BCMA CAR-T therapy, in patients with autoimmune diseases refractory to…
- Trial name
- NCT06935474
- Testing
- C-CAR168
- Where
- United States
- Sponsor
- AbelZeta Inc.
Lupus Nephritis, Lupus Nephritis - World Health Organization (WHO) Class III
KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis
- Conditions
- Lupus Nephritis, Lupus Nephritis - World Health Organization (WHO) Class III, Lupus Nephritis - WHO Class IV
- Trial name
- NCT05938725
- Testing
- KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Kyverna Therapeutics
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
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
A Clinical Study of YTS109 Cells for the Treatment of 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), including LN and SLE-ITP, Sjogren's Syndrome, etc.
- Conditions
- Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN), Sjogren's Syndrome (SS), Inflammatory Myopathy
- Trial name
- NCT07123519
- Testing
- YTS109 cell
- Where
- China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
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
Lupus Nephritis, Lupus Nephritis (LN)
Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus
The purpose of this clinical trial is to evaluate the safety and efficacy of CRC01, an investigational autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, in people with lupus nephritis (LN), a serious kidney…
- Conditions
- Lupus Nephritis, Lupus Nephritis (LN), SLE, SLE (Systemic Lupus)
- Trial name
- CRC01-02 (NCT07364396)
- Testing
- CRC01
- Volunteers
- 39 people
- Sponsor
- Curocell Inc.
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.