Safety and Effectiveness Study of MTS109 Injection for Adults Aged 18 to 65 With Moderate to Severe Autoimmune Diseases Not Responding to Standard Treatments

What this Trial Is About

Researchers are conducting the first human trial of MTS109, an mRNA-LNP drug, to study its safety and tolerability when injected under the skin in people with moderate to severe autoimmune diseases such as systemic lupus erythematosus, idiopathic inflammatory myopathies, systemic sclerosis, ANCA-associated vasculitis, and Sjogrens syndrome. This early phase trial aims to gather important information about how patients respond to this treatment and monitor its effects in these conditions. Participants will receive MTS109 through a series of six subcutaneous injections over four weeks. The dosing starts with a lower dose given on Days 1, 4, and 7, gradually increasing to the target dose, followed by maintenance doses on Days 14, 21, and 28. The study includes three periods a screening phase up to 28 days before treatment, the treatment phase lasting 32 days, and a follow-up phase extending from Month 2 to Month 6 after the first dose. During treatment, safety and drug activity tests will be conducted after each dose, with the first evaluation of efficacy at Day 30. Follow-up visits will include additional safety checks, sample collection, and efficacy assessments, with some visits conducted remotely. Throughout the study, participants will undergo various assessments including safety evaluations, blood and immune system tests to measure drug levels and immune response, and quality of life questionnaires. Researchers will monitor adverse events within 28 days after treatment and evaluate how well participants respond to the drug at several time points up to six months. An interim analysis will occur after at least five participants complete three months of follow-up to assess safety and preliminary benefits. The total participation lasts about six months after dosing, with continued monitoring of safety and immune responses.

MTS109 in Patients With Refractory Autoimmune Diseases