Actively Recruiting
Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
Led by Shanghai Zhongshan Hospital · Updated on 2026-01-05
4
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Graves' disease is an autoimmune thyroid disorder in which autoantibodies against the thyroid-stimulating hormone receptor (TRAb) lead to excessive thyroid hormone production and systemic complications, as well as thyroid eye disease and pretibial myxedema in some cases. Patients with refractory Graves' disease often fail to achieve durable remission despite prolonged antithyroid medication. This study aims to evaluate the safety and efficacy of RD06-05, an allogeneic dual CD19/BCMA CAR-T therapy, in participants with refractory Graves' disease, and will provide preliminary evidence on whether dual-targeting CAR-T therapy can induce sustained remission of refractory Graves' disease.
CONDITIONS
Official Title
Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have refractory Graves' disease defined by either at least 3 years of continuous antithyroid drug treatment without meeting drug discontinuation criteria or at least 2 relapses after drug withdrawal
- Have positive serum TRAb (thyroid-stimulating hormone receptor antibodies)
- Willing to participate voluntarily, able to provide informed consent, and able to comply with follow-up requirements
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Presence or suspicion of uncontrolled or active infections requiring systemic or intravenous treatment
- Presence of central nervous system disorders such as epilepsy, psychosis, stroke, encephalitis, or CNS vasculitis
- Clinically significant heart diseases including angina, myocardial infarction, heart failure, or severe arrhythmias
- Congenital immunoglobulin deficiency
- Current or past malignancy except those considered cured with no risk of recurrence
- Positive viral serology for hepatitis B, hepatitis C, HIV, or syphilis
- Severe psychiatric disorder or significant cognitive impairment affecting compliance
- Hematologic dysfunction including low white blood cell count (<3.5 x 10⁹/L), low neutrophil count (<1.8 x 10⁹/L), or low hemoglobin (<110 g/L)
- Hepatic dysfunction with elevated liver enzymes or bilirubin above specified limits
- Renal dysfunction with creatinine clearance <60 mL/min
- Left ventricular ejection fraction below 55%
- Coagulation abnormalities with INR or prothrombin time >1.5 times the upper limit
- Participation in another clinical trial within 3 months prior to enrollment
- Pregnant or breastfeeding women or those planning pregnancy
- Any condition deemed by the investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
J
Jingjing JIANG, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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