Actively Recruiting
Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
Led by Shanghai Zhongshan Hospital · Updated on 2025-08-19
5
Participants Needed
1
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with refractory Graves disease, defined as at least one of: failure to stop medication after 3 or more years of standard antithyroid therapy; hyperthyroid state needing medicine after 2 or more radioiodine therapies (last dose at least 6 months ago); or at least 2 relapses after stopping medication
- Serum TSH receptor antibody (TRAb) levels at least 3 times above normal (5 IU/L or higher)
- Positive CD19 expression on peripheral blood B cells by flow cytometry
- Willingness to sign informed consent and comply with treatment and follow-up
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Uncontrolled infections requiring intravenous treatment
- Central nervous system disorders including epilepsy, psychosis, stroke, encephalitis, or CNS vasculitis
- Clinically significant heart diseases such as angina, heart attack, heart failure, or severe arrhythmias
- Congenital immunoglobulin deficiency
- Malignant tumors
- Positive tests for HBV DNA, HCV RNA, HIV antibody, or syphilis
- Psychiatric disorders or severe cognitive dysfunction
- Low blood counts: white blood cells under 3.5 x 10^9/L, neutrophils under 1.5 x 10^9/L, hemoglobin under 110 g/L
- Liver function abnormalities: ALT or AST over 3 times normal, bilirubin over 2.5 times normal
- Renal function impairment: creatinine clearance under 60 ml/min
- Heart function impairment: left ventricular ejection fraction under 55%
- Coagulation abnormalities: INR over 1.5 times normal, prothrombin time over 1.5 times normal
- Participation in other clinical trials within 3 months
- Pregnancy or planning pregnancy
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jingjing JIANG, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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