Evaluating Safety and Effectiveness of Allogeneic Anti-CD19BCMA CAR-T Cell Therapy for Adults with Refractory Graves Disease

What this Trial Is About

Graves disease is an autoimmune disorder causing excessive thyroid hormone production, leading to various complications including thyroid eye disease and pretibial myxedema. This trial evaluates the safety and effectiveness of RD06-05, an allogeneic dual CD19BCMA CAR-T therapy, for people with refractory Graves disease who have not achieved remission despite long-term antithyroid medication. The study aims to provide early evidence on whether this dual-targeted CAR-T therapy can induce sustained remission. Participants will receive a single infusion of the allogeneic anti-CD19BCMA CAR-T cells RD06-05. The study is an early phase 1 trial assessing the treatments safety and impact on Graves disease remission over a 12-month period following infusion. No placebo or comparator groups are mentioned. During the study, participants will be monitored for adverse events and disease remission from baseline up to 12 months after the CAR-T cell infusion. Researchers will measure various immune markers, thyroid hormone levels, antibody levels, and thyroid gland volume at specified intervals. They will also track CAR-T cell dynamics and immune responses over the first few months. Participant involvement includes regular follow-up visits and assessments for up to one year after treatment.

Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease