Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease

Launched by SHANGHAI ZHONGSHAN HOSPITAL · Aug 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for Graves' disease, a condition where the immune system mistakenly attacks the thyroid, causing it to produce too much hormone. This can lead to problems throughout the body and sometimes affect the eyes. The trial is testing a special type of therapy called allogeneic anti-CD19 CAR-T, which aims to target and reduce the immune cells responsible for this overactivity in people whose Graves' disease has not improved with standard treatments.

People who may join this study are adults with difficult-to-treat Graves' disease, meaning they have tried usual medications and other treatments like radioiodine therapy but still have symptoms or hormone imbalances. Participants will receive a single dose of the CAR-T therapy and will be closely monitored over time to see how their thyroid hormone levels and symptoms change, as well as to check for any side effects. This study is currently recruiting and looks for people who meet specific health criteria to ensure safety. If you or a loved one has persistent Graves' disease despite treatment, this trial might offer a new option worth discussing with your doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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);
• • Subjects with congenital immunoglobulin deficiency;
• • 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;
• • 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.
• • Participation in other clinical trials within 3 months prior to enrollment;
• • Pregnancy or planning pregnancy;
• • Other conditions considered by investigators as unsuitable for participation.