Actively Recruiting
The Efficacy and Safety of Allogenic Anti-CD19 CAR-T Cell Therapy for Refractory Graves' Disease
Led by Shanghai Zhongshan Hospital · Updated on 2025-08-19
5
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
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 therapy's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with refractory Graves disease, defined by any of the following: failure to stop medication after ≥3 years of standard antithyroid therapy; hyperthyroidism needing medication after ≥2 radioiodine treatments (last dose ≥6 months ago); or ≥2 relapses after stopping medication.
- Serum TRAb level ≥3 times normal (≥5 IU/L).
- Positive CD19 expression on peripheral blood B cells.
- 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 such as epilepsy, psychosis, stroke, encephalitis, or CNS vasculitis.
- Significant heart diseases including angina, myocardial infarction, heart failure, or severe arrhythmias.
- Congenital immunoglobulin deficiency.
- Malignant tumors.
- Positive for hepatitis B (HBsAg or HBcAb) with detectable HBV DNA, hepatitis C antibody with detectable RNA, HIV antibody, or syphilis.
- Psychiatric disorders or severe cognitive dysfunction.
- Low blood counts: WBC <3.5×10^9/L, neutrophils <1.5×10^9/L, hemoglobin <110 g/L.
- Liver dysfunction: ALT or AST >3×ULN, total bilirubin >2.5×ULN.
- Renal dysfunction: creatinine clearance <60 ml/min.
- Cardiac function: left ventricular ejection fraction <55%.
- Coagulation abnormalities: INR ≥1.5×ULN, prothrombin time >1.5×ULN.
- Participation in other clinical trials within 3 months prior.
- Pregnant or planning pregnancy.
- Other conditions deemed unsuitable by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose with follow-up through 12 months
Participants receive one dose of allogeneic CAR-T cell therapy.
1 baseline visit and multiple follow-up visits over 12 months
Duration - Up to 12 months after treatment
Participants are monitored for remission, adverse events, and antibody levels after CAR-T cell infusion.
Regular visits for assessments up to 12 months
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
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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