Study of GT719 Injection for Treating Moderate to Severe Autoimmune Diseases Open-label, Single-group, Early Phase 1 Trial

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how GT719 Injection behaves in the body for patients with moderate to severe autoimmune diseases that have not responded to other treatments. This early-phase, open-label clinical trial will enroll 30 participants to better understand this new biological treatment. The study focuses on patients with systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myopathy. Participants will receive GT719 Injection as the treatment during the study. The trial includes a dose escalation and expansion phase, where the amount of GT719 given may be adjusted. This single-arm study means all participants receive the GT719 Injection without a comparison group. Evaluations for effectiveness will occur at 14 days and then at 1, 2, 3, and 6 months after receiving the infusion. During the study, participants will be monitored closely for any side effects or dose-related toxicities over 28 days and for treatment-related adverse events over a 2-year period. The researchers will assess disease activity using specific clinical scores related to lupus, systemic sclerosis, and inflammatory myopathy at scheduled intervals. The total duration of participation includes follow-up visits over several months to evaluate safety and treatment impact.

GT719 Injection for Moderate to Severe Refractory Autoimmune Disease