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New treatment option for Graves' Disease
Official title Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
ClinicalTrials.gov ID: NCT07261345
What this study is testing
What is allogenic anti-CD19/BCMA CAR-T?
allogenic anti-CD19/BCMA CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for graves' disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- (Participants must meet all of the following 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...
- Positive serum TRAb.
- Willing to voluntarily participate in this clinical study, able to sign informed consent, and compliant with follow-up requirements.
You likely can't join if
- (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...
- 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).
- people with congenital immunoglobulin deficiency.
See the full eligibility criteria
- (Participants must meet all of the following 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...
- Positive serum TRAb.
- Willing to voluntarily participate in this clinical study, able to sign informed consent, and compliant with follow-up requirements.
- (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).
- people with congenital immunoglobulin deficiency.
- people 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.