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Scleroderma, Systemic clinical trials

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NCT ID: NCT06462768 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Neutrophil Extracellular Traps in Different Forms of Systemic Sclerosis

NETOSE
Start date: November 27, 2023
Phase:
Study type: Observational

Systemic SClerosis (SSC) is a systemic disease characterized by limited or diffuse cutaneous sclerosis, microangiopathy, overproduction of autoantibodies and variable organ damage due to vasculopathy and/or fibrosis. The loss of self-tolerance is believed to be caused by the dysregulation of both innate and adaptive immune systems and may involve Reactive Oxygen Species (ROS). Neutrophils are potent producers of ROS and may play a role in endothelial cells and fibrobasts dysfunction, as in autoantibodies generation. However, their role in SSC pathogenesis remains to be determined. Recent studies discovered abnormal regulation of Neutrophil Extracellular Traps (NETs) in other auto-immune diseases such as Systemic Lupus Erythematosus (SLE). NETs are web-like structures composed of chromatin backbones and granular molecules. They are released by activated neutrophils through a process called "NETosis". Nets were first described in 2004 as a novel host defense mechanism to trap and kill foreign pathogens. Recent evidence shows that NETs also participate in the pathogenesis of a variety of inflammatory and autoimmune diseases, including SLE. The investigators recently highlighted this phenomenon in SSc, especially in patients with vascular complications and/or at a early stage of the disease. The investigators will now explore the factors implicated in this dysregulation of NETosis in SSc.

NCT ID: NCT06373081 Recruiting - Systemic Sclerosis Clinical Trials

Anti-CD19-CD3E-CAR-T Cells in Relapsed/Refractory Autoimmune Disease

Start date: April 20, 2024
Phase: N/A
Study type: Interventional

This is an investigator-initiated trial to evaluate the safety and efficacy of anti-CD19-CD3E-CAR-T cells in the relapse or refractory autoimmune diseases.

NCT ID: NCT06361745 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Early Clinical Study of UTAA09 Injection in the Treatment of Relapsed/Refractory Autoimmune Diseases

Start date: April 2, 2024
Phase: N/A
Study type: Interventional

Main purpose: To evaluate the safety of UTAA09 injection in the treatment of relapsed/refractory (R/R) autoimmune disease (AID). Secondary purpose: To evaluate the pharmacokinetic (PK) profile of UTAA09 injection in patients with R/R AID. To evaluate the pharmacodynamic (PD) characteristics of UTAA09 injection in patients with R/R AID. To evaluate the initial efficacy of UTAA09 injection in the treatment of R/R AID subjects. To evaluate the immunogenicity of UTAA09 injection in R/R AID subjects.

NCT ID: NCT06347718 Recruiting - Clinical trials for Systemic Lupus Erythematosus

CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease

CASTLE
Start date: July 17, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4/CD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.

NCT ID: NCT06338722 Recruiting - Clinical trials for Scleroderma, Systemic

Making it Work Program for Systemic Sclerosis

Start date: December 8, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to see if an online intervention program for people with Systemic Sclerosis (scleroderma) helps keep people in the workforce and increase self-confidence in dealing with challenges at work. The program is called Making it Work Systemic Sclerosis. Researchers will compare a group who gets the program to a group who will get the program at a later point in time (wait list control group) to see if self-confidence in dealing with work challenge gets better. People in the Making it Work group will complete questionnaires and attend one 2 hour meetings each week for 5 weeks and meet with an occupational therapist and vocational counselor. People in the wait list control group will complete the questionnaires and participate in the program at a later point in time.

NCT ID: NCT06328777 Recruiting - Systemic Sclerosis Clinical Trials

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

Start date: June 2024
Phase: Phase 1/Phase 2
Study type: Interventional

RESET-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis

NCT ID: NCT06316076 Recruiting - Clinical trials for Systemic Lupus Erythematosus

Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases

Start date: October 30, 2023
Phase: Phase 1
Study type: Interventional

To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases

NCT ID: NCT06195072 Recruiting - Scleroderma Clinical Trials

Platform Clinical Study for Conquering Scleroderma

CONQUEST
Start date: April 1, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to test efficacy of different investigational products (IPs) compared with placebo on the change from baseline to the end of the treatment period at Week 52 in lung capacity in participants with Interstitial Lung Disease Secondary to Systemic Sclerosis.

NCT ID: NCT06149260 Recruiting - Fibrosis Clinical Trials

Subcutaneous Semaglutide in Systemic Scleroderma

Start date: February 29, 2024
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

NCT ID: NCT06133244 Recruiting - Systemic Sclerosis Clinical Trials

Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Start date: April 19, 2024
Phase:
Study type: Observational

Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.