Graves' disease is an autoimmune disease. The TSH receptor antibody(TRab) produced by B cells drives the production of thyroid hormone, which causes systemic disorders and thyroid eye disease. The purpose of this study is to investigate the efficacy and safety of allogeneic anti-CD19 CAR-T for refractory Graves' disease. The participants with refractory Graves' disease will receive a single dose of allogeneic anti-CD19 CAR-T and be regularly seen for the change of serum TRab, FT3, FT4 and clinical presentations, as well as any adverse events.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
The participants will receive one dose of allogeneic CAR-T
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGRemission of Graves disease
Sustained euthyroid status without anti-thyroid medication for ≥3 months
Time frame: From baseline to 12 months after infusion of CAR-T cells
Incidence of Adverse Events
Assessed using the CTCAE v5.0 standards
Time frame: From baseline to 6 months after infusion of CAR-T cells
Anti-Thyrotropin receptor antibody (TRAb)
Serum TRAb titers at 6 months and 12 months after infusion of CAR-T cells
Time frame: From baseline to 12 months after infusion of CAR-T cells
Thyroid stimulating immunoglobulin (TSI)
Serum TSI titers at 6 months and 12 months after infusion of CAR-T cells
Time frame: From baseline to 12 months after infusion of CAR-T cells
thyroid peroxidase antibody (TPOAb)
Serum TPOAb titers at 6 months and 12 months after infusion of CAR-T cells
Time frame: From baseline to 12 months after infusion of CAR-T cells
Thyroglobulin antibody (TgAb)
Serum TgAb titers at 6 months and 12 months after infusion of CAR-T cells
Time frame: From baseline to 12 months after infusion of CAR-T cells
Thyroid volume
Size of thyroid measured and calculated by ultrasound at 6 months and 12 months after infusion of CAR-T cells
Time frame: From baseline to 12 months after infusion of CAR-T cells
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameters - CAR gene copy number
Dynamic change in the CAR gene copy number in peripheral blood after infusion of CAR-T cells
Time frame: From baseline to 3 months after infusion of CAR-T cells
PK parameters - CAR-T cell count
Dynamic change of CAR-T cell count in peripheral blood after infusion of CAR-T cells
Time frame: From baseline to 3 months after infusion of CAR-T cells