Cancer therapy takes on autoimmune thyroid disease
NCT ID NCT07261345
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests a single infusion of genetically modified immune cells (CAR-T cells) in 4 people with refractory Graves' disease, a thyroid condition that doesn't respond well to standard medication. The cells target two proteins (CD19 and BCMA) to reset the immune system. The goal is to see if this approach can safely lead to remission, meaning normal thyroid function without needing daily drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogenic anti-CD19/BCMA CAR-T cells (RD06-05)
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-control Graves' disease, potentially allowing them to stop long-term medication.
- What could go wrong
- This is a very early, small trial with only 4 participants. CAR-T therapy can cause serious side effects, and it's unknown if it will work for Graves' disease or provide lasting benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 4 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two autoimmune conditions, one child: study probes hidden thyroid trouble
- Eye damage in Graves' disease: can early clues predict who is at risk?
- Why does Graves' disease leave some brains exhausted? scientists hunt for clues in blood and spinal fluid
- Hidden thyroid cancers may be more common in Graves' disease than thought
- Can a steroid shot make thyroid surgery safer?
- Targeting the immune system: a new antibody may free Graves' patients from daily drugs