Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
Key facts
- Phase
- Early phase 1
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07129642, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT07129642
- Record updated
- 19 August 2025
- Original description
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.Read full original descriptionShow less
The Efficacy and Safety of Allogenic Anti-CD19 CAR-T Cell Therapy for Refractory Graves' Disease
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.
Inclusion: Subjects with refractory Graves disease, which is defined as meeting any one of the following criteria: a. Failure to discontinue medication after continuous standard antithyroid therapy for ≥ 3 years; b. Hyperthyroid state requiring medication after receiving ≥ 2 times of radioiodine therapy (with the last dose of radioiodine administered at least 6 months prior); c. Relapse ≥ 2 times after cessation of medication upon meeting the criteria for treatment discontinuation; Serum TRAb ≥ 3 times greater than normal range (≥ 5 IU/L); Positive expression of CD19 on peripheral blood B cells determined by flow cytometry; Participation in this clinical study is willing to sign an informed consent with good compliance with treatment and follow-up; (Criteria for treatment discontinuation is define as receiving continuous anti-thyroid drug therapy for ≥18 months, and maintaining euthyroid status for ≥6 months, plus negative TRAb and TSI. Relapse is defined as recurrence of hyperthyroidism and positive TRAb/TSI after meeting the criteria for treatment discontinuation and stopping medication.).
Exclusion: Participation in other clinical trials within 3 months prior to enrollment; History of severe drug allergies or allergic constitution; Presence or suspicion of uncontrolled infections requiring intravenous treatment (fungal, bacterial, viral or other); Presence of central nervous system disorders (including epilepsy, psychosis, cerebrovascular accident, encephalitis, CNS vasculitis, etc); Presence of clinically significant heart diseases (e.g., angina pectoris, myocardial infarction, heart failure, severe arrhythmias, etc); Patients with malignant tumors; Subjects who are: 1. HBsAg or HBcAb positive with detectable peripheral blood HBV DNA; 2. HCV antibody positive with detectable HCV RNA; 3. Positive HIV antibody; 4. Syphilis test positive; Subjects with psychiatric disorders or severe cognitive dysfunction; Other conditions considered by investigators as unsuitable for participation; Hematopoietic function: a. White blood cell count < 3.5×10\^9/L b. Neutrophil count < 1.5 x 10\^9/L; c. Hemoglobin < 110g/L; Liver function: ALT> 3×ULN, AST > 3×ULN, TBIL > 2.5×ULN; Renal function: creatinine clearance rate (CrCl) < 60 ml/minute (calculated based on Cockcroft/Fault formula); Cardiac function: LVEF < 55%; Coagulation function: International standardized ratio (INR) ≥ 1.5×ULN, prothrombin time(PT) >1.5 × ULN; Subjects with congenital immunoglobulin deficiency; Pregnancy or planning pregnancy.