Allogeneic anti‑CD19 CAR‑T therapy for refractory Graves' disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early‑phase study gives one dose of allogeneic anti‑CD19 CAR‑T cells to people with refractory Graves' disease and follows them for changes in serum TRAb, FT3, FT4, clinical symptoms, and adverse events. The approach aims to deplete B cells that produce TSH‑receptor antibodies, the drivers of thyroid hormone overproduction and associated eye disease. Participants must have significantly elevated TRAb and detectable CD19 expression on peripheral B cells and will be followed with frequent clinic visits and laboratory monitoring. The trial is conducted at Zhongshan Hospital, Fudan University, and focuses on safety and signals of clinical effect rather than definitive efficacy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhongshan Hospital Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xiaoying LI, MD, PhD — Fudan University
• Study coordinator: Jingjing JIANG, MD, PhD
• Email: jiang.jingjing@zs-hospital.sh.cn
• Phone: 86-021-64041990

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.