Actively Recruiting
The Safety and Efficacy of Allogenic Anti-CD19/BCMA CAR-T Cell Therapy for Refractory Graves' Disease
Led by Shanghai Zhongshan Hospital · Updated on 2026-01-05
4
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Graves' disease is an autoimmune disorder causing excessive thyroid hormone production, leading to various complications including thyroid eye disease and pretibial myxedema. This trial evaluates the safety and effectiveness of RD06-05, an allogeneic dual CD19/BCMA CAR-T therapy, for people with refractory Graves' disease who have not achieved remission despite long-term antithyroid medication. The study aims to provide early evidence on whether this dual-targeted CAR-T therapy can induce sustained remission. Participants will receive a single infusion of the allogeneic anti-CD19/BCMA CAR-T cells (RD06-05). The study is an early phase 1 trial assessing the treatment's safety and impact on Graves' disease remission over a 12-month period following infusion. No placebo or comparator groups are mentioned. During the study, participants will be monitored for adverse events and disease remission from baseline up to 12 months after the CAR-T cell infusion. Researchers will measure various immune markers, thyroid hormone levels, antibody levels, and thyroid gland volume at specified intervals. They will also track CAR-T cell dynamics and immune responses over the first few months. Participant involvement includes regular follow-up visits and assessments for up to one year after treatment.
CONDITIONS
Brief Title
Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of refractory Graves' disease, defined as either continuous antithyroid drug treatment for 3 or more years without eligible drug discontinuation, or 2 or more relapses after drug withdrawal
- Positive serum thyroid-stimulating hormone receptor antibody (TRAb)
- Willingness to voluntarily participate and ability to sign informed consent
- Ability to comply with follow-up requirements
- Age between 18 and 75 years
You will not qualify if you...
- History of severe drug allergies or allergic constitution
- Uncontrolled or active infections requiring systemic or intravenous treatment
- Central nervous system disorders including epilepsy, psychosis, stroke, encephalitis, or CNS vasculitis
- Clinically significant heart diseases such as angina, myocardial infarction, heart failure, or severe arrhythmias
- Congenital immunoglobulin deficiency
- Current or past malignancy except those cured and with no risk of recurrence
- Positive viral infections including hepatitis B or C, HIV, or syphilis
- Severe psychiatric disorders or significant cognitive impairment
- Hematologic dysfunction including low white blood cell, neutrophil counts, or hemoglobin
- Liver dysfunction with elevated ALT, AST, or bilirubin
- Kidney dysfunction with creatinine clearance below 60 mL/min
- Left ventricular ejection fraction below 55%
- Coagulation abnormalities with elevated INR or prothrombin time
- Participation in another clinical trial within 3 months prior to enrollment
- Pregnant or breastfeeding women, or women planning pregnancy
- Any condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment day
Participants will receive a single infusion of allogenic anti-CD19/BCMA CAR-T cells.
1 treatment visit (in-person)
Duration - 12 months
Participants are monitored for safety and efficacy outcomes for 12 months after infusion of CAR-T cells.
Regular visits during 12 months post-infusion
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
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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