Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic CAR-T.
- Who it may be relevant to
- Registry conditions: Graves Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy and Safety of Allogenic Anti-CD19 CAR-T Cell Therapy for Refractory Graves' Disease
Overview
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.
Interventions
- Biological Allogeneic CAR-T
The participants will receive one dose of allogeneic CAR-T
Primary outcome measures
- Remission of Graves disease [Time frame: From baseline to 12 months after infusion of CAR-T cells]
- Incidence of Adverse Events [Time frame: From baseline to 6 months after infusion of CAR-T cells]
Secondary outcome measures (7)
- Anti-Thyrotropin receptor antibody (TRAb) [Time frame: From baseline to 12 months after infusion of CAR-T cells]
- Thyroid stimulating immunoglobulin (TSI) [Time frame: From baseline to 12 months after infusion of CAR-T cells]
- thyroid peroxidase antibody (TPOAb) [Time frame: From baseline to 12 months after infusion of CAR-T cells]
- Thyroglobulin antibody (TgAb) [Time frame: From baseline to 12 months after infusion of CAR-T cells]
- Thyroid volume [Time frame: From baseline to 12 months after infusion of CAR-T cells]
- PK parameters - CAR gene copy number [Time frame: From baseline to 3 months after infusion of CAR-T cells]
- PK parameters - CAR-T cell count [Time frame: From baseline to 3 months after infusion of CAR-T cells]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital Fudan University — Shanghai
Identifiers
NCT: NCT07129642 · B2025-217R