Experimental CAR-T therapy aims to tame stubborn Graves' disease
NCT ID NCT07333677
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests HN2301, a new type of CAR-T therapy given directly into the blood, for people with refractory Graves' disease—a thyroid condition that doesn't respond well to standard treatments. The therapy reprograms the body's own immune cells to target and calm the overactive immune response. Five participants will receive several doses and be monitored for safety and signs of remission over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HN2301 (in vivo CAR-T therapy)
- What this could lead to
- If it works, this could offer a new treatment option for people with refractory Graves' disease, potentially achieving remission without long-term medication.
- What could go wrong
- This is a very early, small trial with only 5 participants. The therapy is experimental, and safety and effectiveness are not yet proven. There may be unknown side effects.
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 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- 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.
Show the full entry requirements Hide the full entry requirements
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 criteria to be eligible for this study): * Age 18-75 years (inclusive), male or female. * Refractory Graves' disease, defined as meeting at least one of the following: a) Continuous antithyroid drug (ATD) therapy for ≥3 years without achieving criteria for ATD discontinuation; b) Meeting criteria for ATD discontinuation but experiencing ≥2 relapses after ATD withdrawal. * Positive serum TRAb. * Willing to use effective contraception for 12 months after study drug administration. * Voluntarily agrees to participate in the study, has signed the informed consent form, and is able to comply with study procedures and follow-up requirements. Exclusion Criteria (Participants meeting any of the following criteria will be excluded from the study): * History of severe drug allergy or known allergic predisposition. * Presence or suspected presence of uncontrolled active infection. * History of major organ transplantation (e.g., heart, lung, liver, kidney) or bone marrow/hematopoietic stem cell transplantation. * Presence of significant heart disease, such as angina, myocardial infarction, heart failure, or clinically significant arrhythmias. * Receipt of any mRNA-LNP product or other lipid nanoparticle (LNP)-based therapy within the past 2 years. * Receipt of a live vaccine within 30 days prior to screening. * History of malignant tumors. * Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA above the detection limit; positive hepatitis C virus (HCV) antibody with detectable HCV RNA; positive human immunodeficiency virus (HIV) antibody; or positive syphilis test. * Presence of psychiatric disorders or severe cognitive impairment. * Hematologic dysfuction at screening, defined as any of the following: a. Neutrophil count \< 1.8 × 10⁹/L, b. Hemoglobin \< 110 g/L, c. Platelet count \< 50 × 10⁹/L * Impaired liver function, defined as any of the following: Alanine aminotransferase (ALT) \> 3 × ULN, Aspartate aminotransferase (AST) \> 3 × ULN, Total bilirubin \> 2.5 × ULN. * Impaired renal function: 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 * Pregnant or breastfeeding women. * 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