Study of EVM18001 Injection for Treating Active Refractory Systemic Lupus Erythematosus, Myasthenia Gravis, and Scleroderma in Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, and dosing of EVM18001 injection in adults with active refractory autoimmune diseases including Systemic Lupus Erythematosus SLE, Myasthenia Gravis MG, and Scleroderma SSc. The study also aims to observe preliminary effectiveness, understand the drugs pharmacokinetics and pharmacodynamics PKPD, and explore related biomarkers and immunogenicity. This is a first-in-human, single-arm, open-label Investigator Initiated Trial IIT. All participants will receive multiple doses of EVM18001 based on their assigned dosage group. The treatment schedule involves repeated dosing with close monitoring over time. The study does not include a placebo group and focuses on evaluating this biological treatments effects in patients who have not responded well to standard therapies. Participants will have regular visits to monitor their health, including assessments of safety through rates and severity of adverse events. The study will also measure drug levels, immune cell markers, and treatment response using various tests. Safety, efficacy, and dosing recommendations will be evaluated over a 24-month period. Participants must inform investigators about health changes and medication use, and females and males of reproductive potential must agree to use effective contraception during the study and for 12 months after the last dose.

Clinical Study of EVM18001 in the Treatment of Refractory Autoimmune Diseases