Lupus

Systemic lupus erythematosus (SLE) is an autoimmune disease affecting multiple body systems, with skin involvement being one of the earliest and most common features. This research evaluates the role of TREX1 gene mutations and certain autoantibodies in SLE, especially how these genetic factors relate to skin symptoms and disease activity. The study focuses on understanding these connections in Egyptian patients to improve early diagnosis and personalized treatment. The study involves about 60 patients diagnosed with SLE who have at least one skin manifestation, compared with 30 healthy volunteers matched by age and sex. Researchers will assess selected autoantibodies and TREX1 gene polymorphisms to explore their prevalence and connection to clinical features. This is an observational study without treatment interventions. Participants will provide informed consent and undergo genetic testing and autoantibody assessments. Researchers will monitor disease activity and gene polymorphisms over a 3-month period. The study aims to correlate genetic and antibody findings with disease symptoms and activity to better understand SLE's impact on the skin and overall health.

Researchers are studying pulmonary arterial hypertension (PAH), including its common subtypes idiopathic PAH (IPAH) and connective tissue disease-associated PAH (PAH-CTD). The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance (6MWD) are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups: 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.

Researchers are evaluating litifilimab (BIIB059), a monoclonal antibody, in adults with active cutaneous lupus erythematosus (CLE). This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus (SLE), who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts: Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are evaluating the safety, effectiveness, and cell metabolism of ct1195e cells in adults with moderate to severe refractory Systemic Lupus Erythematosus (SLE). This early phase 1 study explores dose levels and cellular responses to better understand this therapy's potential. The trial aims to find the maximum tolerated dose and assess side effects and disease activity over time. Participants receive infusions of CT1195E CAR-T cells in a two-stage process: an initial dose escalation phase with three planned dose levels (3.0 x 10^8, 4.5 x 10^8, and 6.0 x 10^8 cells) followed by a dose expansion phase selecting one or more dose groups for further evaluation. Dose decisions are based on safety, tolerance, and cell metabolism, with a 28-day dose-limiting toxicity observation period after infusion. During the study, participants are monitored through assessments of toxicity, adverse events, and SLE disease activity using various clinical scores and biomarker changes. Follow-up includes evaluations at multiple time points up to one year to measure cell gene presence and immune function. Safety data and disease responses guide ongoing treatment decisions and participant management throughout the trial.

Researchers are investigating the safety and effectiveness of CD19 CAR-T cell therapy for adults with active systemic lupus erythematosus (SLE), a disease where current treatments often struggle to control symptoms or cause serious side effects. This study aims to address the need for better treatment options by exploring how this cell therapy works and how well patients tolerate it. It is a Phase 1 and Phase 2 clinical trial conducted by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants in the study will receive an intravenous infusion of CD19 CAR-T cells. After the infusion, patients will be followed for up to two years. The study involves monitoring various outcomes including safety, how the therapy moves and acts in the body, and changes in disease activity and immune markers. Regular assessments will take place at multiple time points during the follow-up period to track response and side effects. During the study, participants will have scheduled visits for clinical evaluations, blood tests, and questionnaires to measure disease activity and immune system changes. Researchers will look at safety and tolerability over two years, along with detailed lab tests such as antibody levels, complement proteins, and lupus severity indexes. This long-term follow-up helps understand the therapy’s effects and any risks, supporting comprehensive monitoring of participant health throughout the study.

Researchers are studying CD19 Universal CAR-b3b4T cells as a potential treatment for adults with active severe systemic lupus erythematosus (SLE), a condition where current therapies often fail to fully control disease activity. This study aims to assess the safety, tolerability, early effectiveness, and how the body processes and responds to these CAR-T cells. The trial is led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Participants will receive an intravenous infusion of CD19 Universal CAR-b3b4 T Cells. The study includes a treatment phase where the cells are given, followed by a long-term follow-up period lasting up to two years. During this time, researchers will monitor various health and disease activity markers to understand the treatment's effects. Throughout the study, participants will have regular visits for assessments including safety checks, disease activity scores (SELENA-SLEDAI and Physician Global Assessment), immunological tests, and levels of specific antibodies in the blood. Researchers will track these outcomes at multiple time points up to 24 months after infusion. This follow-up ensures close monitoring of participant health and how the therapy interacts with their condition over time.

Researchers are evaluating the safety and tolerability of QT-019B, a dual-target, universal CAR-T cell therapy for adults with refractory systemic lupus erythematosus (SLE). This phase I/IIa clinical study aims to determine the recommended dose (RD) and understand how the treatment affects disease activity in patients who have not responded to standard therapies. The study is sponsored by Hangzhou Qihan Biotech Co., Ltd. and plans to enroll between 18 and 24 participants. The study consists of two main phases: dose escalation and dose expansion. Initially, participants receive a QT-019B cell injection at Dose A (1×10^6/kg), with a 14-day interval between enrollments. If no dose-limiting toxicities (DLTs) are observed during the observation period, the study may proceed to Dose B (3×10^6/kg). If DLTs occur, additional participants may be enrolled at Dose A, or the study dose may be reduced or the study terminated depending on the number of DLTs observed. Participants will be closely monitored through safety assessments including tracking adverse events within 28 days of treatment. Researchers will also evaluate changes in disease activity scores such as the SLEDAI-2000, Physician's Global Assessment, and BILAG-2004 Index over up to two years. Blood samples will be collected to measure the concentration and behavior of QT-019B cells. The overall study involves regular visits, assessments, and follow-up to comprehensively evaluate safety and treatment impact over time.

Researchers are evaluating the safety and tolerability of a study medicine called MK-1045 in adults with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The study focuses on understanding how people respond to different dose levels of MK-1045. This research is sponsored by Merck Sharp & Dohme LLC and is designed as a Phase 1 clinical trial to assess safety and how the drug behaves in the body over time. Participants will receive MK-1045 through intravenous (IV) infusions. The dosing plan includes single intravenous doses at varying levels, as well as a series of three step-up doses over a three-week period, progressing from a prime dose to a target dose. The study is randomized, with participants assigned to different dosing panels to evaluate safety and drug behavior at each stage. During the study, participants will be monitored for side effects, including any adverse events and the reasons for stopping the study drug. Blood tests will measure how much MK-1045 is in the body and the effect on B cell counts at various times up to 52 weeks. Safety and drug effects are carefully tracked with follow-ups lasting up to approximately one year. Overall participation may last for several months, depending on the study part.

Researchers are evaluating an open-label, dose escalation study for patients with relapsed and refractory autoimmune diseases. The study focuses on a therapeutic biological product called TI-0032-III injection, which uses lipid nanoparticles to deliver circular RNA encoding the CD19 chimeric antigen receptor (CAR) targeting T cells. This treatment is intended for various difficult-to-treat B cell-related autoimmune diseases, including systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, idiopathic inflammatory myositis, and antiphospholipid syndrome. Participants will receive multiple doses of TI-0032-III injection infused into the body. This in vivo CD19-targeted CAR T cell therapy is being studied for safety and efficacy, with treatment delivered over a period involving dose escalation. The trial is an interventional Phase 1 study where the investigational injection is the main intervention. During the study, participants will be monitored for safety outcomes from the first dose up to 12 months. Researchers will also assess efficacy outcomes for the different autoimmune diseases up to 3 months after the first dose. Evaluations include clinical assessments and laboratory tests to measure treatment impact and safety. The total participant involvement will span at least one year to observe safety and disease response.

Researchers are studying the safety and effectiveness of YTS109 cells in adults aged 18 to 65 with relapsed or refractory autoimmune diseases, including Systemic Lupus Erythematosus (SLE) and related conditions such as Lupus Nephritis (LN), SLE-associated immune thrombocytopenia, Sjogren's Syndrome, systemic sclerosis, inflammatory myopathy, ANCA-associated vasculitis, and antiphospholipid syndrome. This phase 1, open-label study aims mainly to evaluate safety and also to examine how well YTS109 cells work and behave in the body. Participants will receive a single infusion of YTS109 cells, starting at a dose of 3×10⁶ STAR-T cells per kilogram of body weight. The dosing will follow a 3+3 escalation design to carefully adjust the dose. There is only one treatment group in this study. The infusion is a one-time procedure during the treatment period. During the study, participants will be closely monitored through regular assessments up to 52 weeks after treatment. Safety is tracked by observing adverse events and their severity. Effectiveness is assessed at multiple time points from 2 to 52 weeks. Blood tests will measure YTS109 cell levels, cytokine changes, and B cell recovery. Participants must agree to informed consent and follow-up visits to complete all evaluations throughout the study duration.