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Scleroderma, Systemic clinical trials

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NCT ID: NCT06373263 Not yet recruiting - Systemic Sclerosis Clinical Trials

Evaluating Tools to Communicate Scleroderma Research Results to Patients

SPIN-KT
Start date: June 2024
Phase: N/A
Study type: Interventional

Sharing research results with patients is required by ethical regulations. Yet, most researchers do not share results from their studies with patients. The investigators plan to conduct a series of randomized controlled trials among people with scleroderma, a rare autoimmune disease, in a large international cohort, to identify the most effective methods for communicating study results with patients. The first trial in the series will compare a research dissemination tool (infographic) against a plain-language summary comparator. Participants will be randomly assigned to receive the dissemination tool or comparator. Study participants will rate communication tools for (1) information completeness; (2) understandability; and (3) ease of use of format. Our results can be used by researchers and patient organizations who disseminate research results so that they can tailor the way they disseminate results to patient needs.

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: NCT06350110 Not yet recruiting - Clinical trials for Systemic Lupus Erythematosus

Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)

BAH242
Start date: November 10, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.

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: NCT06333795 Not yet recruiting - Diarrhea Clinical Trials

Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis

FaeMiCue
Start date: April 1, 2024
Phase: N/A
Study type: Interventional

This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.

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: NCT06297096 Not yet recruiting - Systemic Sclerosis Clinical Trials

Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease

NINTOC-TU
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

The study includes adult patients with systemic sclerosis (SSc) with interstitial lung disease (ILD) to evaluate the efficacy and safety of nintedanib plus tocilizumab combination therapy compared to standard therapy (methotrexate, mycophenolate mofetil) for 56 weeks.