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

Recruiting now · Early Phase 1

Conditions studied: Graves Disease

In brief

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.

Key facts

Study ID: NCT07129642
Run by: Shanghai Zhongshan Hospital
People needed: 5
Starts: 2025-08-10
Expected to finish: 2027-03-31
Last updated by the study team: 2025-08-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.)

You may not qualify if…

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 is running

Zhongshan Hospital Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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