Actively Recruiting
Early Phase 1 Study of Allogeneic Anti-CD19 CAR-T Cell Therapy for Adults with Refractory Graves Disease
Led by Shanghai Zhongshan Hospital · Updated on 2025-08-19
5
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying allogeneic anti-CD19 CAR-T cell therapy as a potential treatment for refractory Graves disease, an autoimmune disorder where antibodies cause excess thyroid hormone production leading to systemic problems and thyroid eye disease. This early-phase study aims to evaluate the therapys effectiveness and safety in patients whose Graves disease has not responded to standard treatments. Participants will receive a single dose of the allogeneic anti-CD19 CAR-T cells. After the infusion, they will be monitored regularly over the following months to assess changes in thyroid-related antibodies such as TRAb, FT3, and FT4, as well as clinical symptoms. The study includes tracking adverse events and therapy persistence through measurements like CAR gene copy number and CAR-T cell count. During the study, participants will undergo assessments of thyroid function, antibody levels, thyroid volume, and clinical presentations at various time points up to 12 months post-infusion. Safety will be monitored closely for six months. This comprehensive follow-up aims to understand how the therapy affects disease remission and any side effects, with total participation lasting at least one year.
CONDITIONS
Brief Title
Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
Research Team
J
Jingjing JIANG, MD, PhD
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