Clinical trials: Refractory Autoimmune Diseases
Neurological Autoimmune Diseases
A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune Diseases
This study is a single-arm, open-label, non-randomized clinical trial aimed at evaluating the safety, tolerability and preliminary efficacy of HY001N cell injection in the treatment of patients with relapsed/refractory…
- Trial name
- NCT07265206
- Testing
- HY001N cell injection
- Volunteers
- 15 people
- Sponsor
- Juventas Cell Therapy Ltd.
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.
Lupus Nephritis
Universal CAR-T Cell Therapy for Refractory Lupus Nephritis
This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.
- Trial name
- NCT06681337
- Testing
- BCMA CART + CD19 CART
- Volunteers
- 10 people
- Sponsor
- Bioray Laboratories
Autoimmune Diseases
CAR-T Therapy for Refractory Autoimmune Diseases
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases.
- Trial name
- NCT07059169
- Testing
- JY231 (JY231 injection)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- LiangZou
Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS)
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refractory Autoimmune Diseases
This is an open-label, dose escalation study in patients with relapsed and refractory autoimmune diseases. Study drug, TI-0032-III injection, is composed of lipid nanoparticles (LNPs) targeting T cells that encapsulate circular…
- Conditions
- Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome (SS), Systemic Sclerosis (SSc), Inflammatory Myopathy
- Trial name
- in vivo CAR-T (NCT07413341)
- Testing
- TI-0032-III injection
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Therorna
Wegener's Granulomatosis
Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis
Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys.
- Trial name
- NCT00530075
- Testing
- Gusperimus
- Where
- 7 sites in Czechia, Denmark and 4 more
- Volunteers
- 45 people
- Sponsor
- Nippon Kayaku Co., Ltd.
SLE - Systemic Lupus Erythematosus
CD19/BCMA CAR-T for SLE
The purpose of this clinical trial is to learn if CD19/BCMA CAR-T works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the CD19/BCMA CAR-T cell product.
- Trial name
- NCT07266337
- Testing
- CD19/BCMA CAR T-cells
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
Autoimmune Diseases
Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory Autoimmune Diseases
The goal of this study is to evaluate the safety and efficacy of CD19 CAR T cells in the treatment of Refractory Autoimmune Diseases
- Trial name
- NCT07161193
- Testing
- CD19 CAR-T cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Hebei Senlang Biotechnology Inc., Ltd.
IgA Nephropathy (IgAN), Membranous Nephropathy
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
This study is a single-arm, open-label, dose-escalation and dose-expansion clinical trial, divided into two phases: the first phase is the dose-escalation phase, and the second phase is the dose-expansion phase.
- Conditions
- IgA Nephropathy (IgAN), Membranous Nephropathy, ANCA-associated Vasculitis (AAV)/ANCA-associated Glomerulonephritis (AAGN), Refractory Podocytopathy
- Trial name
- NCT07389499
- Testing
- CD19-targeted iNKT Cell Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
Systemic Lupus Erythematosus, Lupus Nephritis
An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus
The study is intended to assess safety, efficacy and cellular kinetics of YTB323 treatment in participants with severe refractory systemic lupus erythematosus.
- Trial name
- NCT05798117
- Testing
- YTB323
- Where
- 10 sites in Australia, France and 3 more
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Auto Immune Disease
GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to…
- Trial name
- NCT07132112
- Testing
- GT719 Injection
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Grit Biotechnology
Arthritis, Rheumatoid
A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488
This multicenter, open-label, single-arm extension study will evaluate the long-term safety of tocilizumab (RoActemra/Actemra) in participants with RA.
- Trial name
- RITACT (NCT01715831)
- Testing
- DMARDs, Tocilizumab
- Where
- 9 sites in Brazil
- Volunteers
- 26 people
- Sponsor
- Hoffmann-La Roche
Progressive Multiple Sclerosis
Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
The main purpose of this study is to evaluate if obe-cel is safe or causes any side effects in adults with refractory progressive MS. The study also plans to assess if obe-cel can show early signs of efficacy in MS.
- Trial name
- BOBCAT (NCT07139743)
- Testing
- Obecabtagene autoleucel (obe-cel)
- Where
- 7 sites in United States, Spain and 1 more
- Volunteers
- 24 people
- Sponsor
- Autolus Limited
CMV Retinitis
Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.
The goal of this exploratory clinical study is to evaluate the safety and efficacy of Cytomegalovirus-Specific T cells (LB-DTK-CMV) to treat patients diagnosed with antiviral-resistant and refractory cytomegalovirus retinitis.
- Trial name
- NCT07679412
- Testing
- LB-DTK-CMV
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- LucasBio
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
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
Refractory Generalized Myasthenia Gravis
Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis
To evaluate the safety and efficacy of eculizumab in the treatment of refractory generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study ECU-MG-301(NCT01997229).
- Trial name
- NCT02301624
- Testing
- Eculizumab
- Where
- 60 sites in United States, Argentina and 15 more
- Volunteers
- 117 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Thrombocytopenia, Idiopathic Thrombocytopenic Purpura
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
The purpose of this study is to evaluate the efficacy of AMG 531 in the treatment of thrombocytopenia in subjects with ITP as measured by the platelet response.
- Trial name
- NCT00102323
- Testing
- AMG 531
- Volunteers
- 63 people
- Sponsor
- Amgen
Myasthenia Gravis, Myasthenia Gravis, Juvenile Form
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis…
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
- Trial name
- NCT03759366
- Testing
- Eculizumab
- Where
- 11 sites in United States, Japan
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Systemic Lupus Erythematosus (SLE), Systemic Sclerosis
Exploratory Clinical Study on YTS109 Cell Therapy for 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), Systemic Sclerosis, Sjogren's Syndrome (SS), Inflammatory Myopathy
- Trial name
- NCT07236801
- Testing
- YTS109 cell
- Where
- 2 sites in China
- Volunteers
- 18 people
- Sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.