Phase 1b Study of Cizutamig Treatment in Adults with Generalized Myasthenia Gravis

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical effects of Cizutamig in adults with Generalized Myasthenia Gravis gMG. This is a Phase 1b, open-label, multicenter study designed to better understand how this drug behaves and works in patients with this condition who have not responded well to other treatments. Participants will receive Cizutamig dosed according to the study protocol. The study does not use a placebo or control group and is open-label, meaning both researchers and participants know the treatment being given. The treatment period and follow-up extend through 12 months to monitor various health and safety measures. During the study, participants will undergo regular assessments including vital signs temperature, heart rate, respiratory rate, blood pressure, pulse oximetry, ECGs, and laboratory tests for serum chemistry and blood counts. Researchers will track adverse events, drug levels in the body, and immune responses up to one year to evaluate the drugs safety and how the body processes it. Participants daily living activities related to Myasthenia Gravis will also be considered.

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)