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In Vivo CAR-T for Refractory Graves' Disease
Sponsor: Shanghai Zhongshan Hospital
Summary
Graves' disease is an autoimmune thyroid disorder characterized by the production of autoantibodies against the thyroid-stimulating hormone receptor (TRAb), leading to excessive thyroid hormone secretion and systemic manifestations. A subset of patients develop refractory disease, failing to achieve durable remission despite prolonged antithyroid therapy. This study aims to evaluate the safety and efficacy of HN2301, an in vivo CAR-T therapy in which host T lymphocytes are engineered and transformed to functional CAR-T cells via CD8 antibody-coated LNP delivery of CD19 CAR-mRNA. Participants with refractory Graves' disease will receive three to five administrations of HN2301 and will be regularly monitored for changes in thyroid function, TRAb levels, clinical response, and treatment-related adverse events. The study will provide preliminary evidence on whether HN2301 can induce sustained remission of refractory Graves' disease.
Official title: A Safety and Efficacy Study of in Vivo CAR-T (HN2301) for Refractory Graves' Disease
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
5
Start Date
2026-01-29
Completion Date
2027-12
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
In Vivo CAR-T Therapy
Participants will receive 3 to 5 intravenous administrations of HN2301, given once every 2 days, according to the study dosing regimen.
Locations (1)
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China