NCT07261345 Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
| NCT ID | NCT07261345 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Graves' Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 4 participants |
| Start Date | 2025-12-19 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 4 participants in total. It began in 2025-12-19 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria (Participants must meet all of the following inclusion criteria to be eligible for this study): * Refractory Graves' disease, defined as meeting at least one of the following: a) Continuous treatment with antithyroid drugs (ATDs) for ≥3 years without achieving criteria for drug discontinuation. b) Meeting criteria for drug discontinuation but experiencing ≥2 relapses after withdrawal. * Positive serum TRAb. * Willing to voluntarily participate in this clinical study, able to sign informed consent, and compliant with follow-up requirements. Exclusion Criteria (Participants will be excluded if any of the following conditions apply): * History of severe drug allergies or allergic constitution. * Presence or suspected presence of uncontrolled or active infections (including bacterial, fungal, viral, or other pathogens) requiring systemic or intravenous treatment. * 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. * Subjects with malignancy (current or past), except for conditions deemed cured and with no risk of recurrence based on investigator assessment. * Positive viral serology, including any of the following: Hepatitis B surface antigen (HBsAg)-positive, or hepatitis B core antibody (HBcAb)-positive with HBV DNA above the upper limit; Hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; Human immunodeficiency virus (HIV) antibody-positive; Positive syphilis test. * Severe psychiatric disorder or significant cognitive impairment that may affect compliance. * Hematologic dysfunction, including: a) White blood cell count \< 3.5 × 10⁹/L; b) Neutrophil count \< 1.8 × 10⁹/L; c) Hemoglobin \< 110 g/L. * Hepatic dysfunction, defined as any of the following: Alanine aminotransferase (ALT) \> 3 × ULN; Aspartate aminotransferase (AST) \> 3 × ULN; Total bilirubin (TBIL) \> 2.5 × ULN. * Renal dysfunction: creatinine clearance rate (CrCl) \< 60 mL/min (Cockcroft-Gault formula). * Left ventricular ejection fraction (LVEF) \< 55%. * Coagulation abnormalities, defined as either: International normalized ratio (INR) \> 1.5 × ULN; Prothrombin time (PT) \> 1.5 × ULN. * Participation in another clinical trial within 3 months prior to enrollment. * Pregnant or breastfeeding women, or women planning to become pregnant. * Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07261345 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Graves' Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07261345 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07261345 currently recruiting?
Yes, NCT07261345 is actively recruiting participants. Contact the research team at jiang.jingjing@zs-hospital.sh.cn for enrollment information.
Where is the NCT07261345 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07261345 clinical trial?
NCT07261345 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 4 participants.