Graves DiseaseEarly Phase 1NCT07129642
Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
A Early Phase 1 study testing Allogeneic CAR-T in people with Graves Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Graves' disease is an autoimmune disease. The TSH receptor antibody(TRab) produced by B cells drives the production of thyroid hormone, which causes systemic disorders and thyroid eye disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- Allogeneic CAR-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2025to 31 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with refractory Graves disease, which is defined as meeting any one of the following criteria: a. Failure to discontinue medication after continuous standard antithyroid therapy for ≥ 3 years; b. Hyperthyroid state requiring medication after receiving ≥ 2 times of radioiodine therapy (with the last dose of radioiodine administered at least 6 months prior); c. Relapse ≥ 2 times after cessation of medication upon meeting the criteria for treatment discontinuation.
- Serum TRAb ≥ 3 times greater than normal range (≥ 5 IU/L)
- Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
- Participation in this clinical study is willing to sign an informed consent with good compliance with treatment and follow-up.
- (Criteria for treatment discontinuation is define as receiving continuous anti-thyroid drug therapy for ≥18 months, and maintaining euthyroid status for ≥6 months, plus negative TRAb and TSI. Relapse is defined as recurrence of hyperthyroidism and positive TRAb/TSI after meeting the criteria for treatment discontinuation and stopping medication.)
Who cannot join
- History of severe drug allergies or allergic constitution;
- Presence or suspicion of uncontrolled infections requiring intravenous treatment (fungal, bacterial, viral or other);
- 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;
- Patients with malignant tumors;
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- Subjects who are: 1. HBsAg or HBcAb positive with detectable peripheral blood HBV DNA; 2. HCV antibody positive with detectable HCV RNA; 3. Positive HIV antibody; 4. Syphilis test positive;
- Subjects with psychiatric disorders or severe cognitive dysfunction;
- Hematopoietic function: a. White blood cell count < 3.5×10^9/L b. Neutrophil count < 1.5 x 10^9/L; c. Hemoglobin < 110g/L.
- Liver function: ALT> 3×ULN, AST > 3×ULN, TBIL > 2.5×ULN.
- Renal function: creatinine clearance rate (CrCl) < 60 ml/minute (calculated based on Cockcroft/Fault formula).
- Cardiac function: LVEF < 55%
- Coagulation function: International standardized ratio (INR) ≥ 1.5×ULN, prothrombin time(PT) >1.5 × ULN.
- Participation in other clinical trials within 3 months prior to enrollment;
- Pregnancy or planning pregnancy;
- Other conditions considered by investigators as unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Jingjing JIANG, MD, PhD, 86-021-64041990, jiang.jingjing@zs-hospital.sh.cn
About this study
Official title: The Efficacy and Safety of Allogenic Anti-CD19 CAR-T Cell Therapy for Refractory Graves' Disease
Graves' disease is an autoimmune disease. The TSH receptor antibody(TRab) produced by B cells drives the production of thyroid hormone, which causes systemic disorders and thyroid eye disease. The purpose of this study is to investigate the efficacy and safety of allogeneic anti-CD19 CAR-T for refractory Graves' disease.
The participants with refractory Graves' disease will receive a single dose of allogeneic anti-CD19 CAR-T and be regularly seen for the change of serum TRab, FT3, FT4 and clinical presentations, as well as any adverse events.
- Conditions
- Graves Disease
- Being tested
- Allogeneic CAR-T
- Keywords
- CAR-T, refractory Graves disease, TSH receptor antibody
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic CAR-TBiological
The participants will receive one dose of allogeneic CAR-T
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Not described Receives: Biological: Allogeneic CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of Graves disease
Sustained euthyroid status without anti-thyroid medication for ≥3 months
Measured: From baseline to 12 months after infusion of CAR-T cells
Incidence of Adverse Events
Assessed using the CTCAE v5.0 standards
Measured: From baseline to 6 months after infusion of CAR-T cells
Secondary outcomes (7)
Anti-Thyrotropin receptor antibody (TRAb)
Serum TRAb titers at 6 months and 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Thyroid stimulating immunoglobulin (TSI)
Serum TSI titers at 6 months and 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
thyroid peroxidase antibody (TPOAb)
Serum TPOAb titers at 6 months and 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Thyroglobulin antibody (TgAb)
Serum TgAb titers at 6 months and 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Thyroid volume
Size of thyroid measured and calculated by ultrasound at 6 months and 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
PK parameters - CAR gene copy number
Dynamic change in the CAR gene copy number in peripheral blood after infusion of CAR-T cells
Measured: From baseline to 3 months after infusion of CAR-T cells
PK parameters - CAR-T cell count
Dynamic change of CAR-T cell count in peripheral blood after infusion of CAR-T cells
Measured: From baseline to 3 months after infusion of CAR-T cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start10 Aug 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoying Li, Shanghai Zhongshan Hospital
- Investigators
- Xiaoying LI, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129642
- Sponsor's protocol ID
- B2025-217R
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Allogenic Anti-CD19 CAR-T Cell Therapy for Refractory Graves' Disease
- ClinicalTrials.gov ID
- NCT07129642
- Acronym / sponsor ID
- B2025-217R
- Conditions
- Graves Disease
- Keywords
- CAR-T, refractory Graves disease, TSH receptor antibody
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 10 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Graves' disease is an autoimmune disease. The TSH receptor antibody(TRab) produced by B cells drives the production of thyroid hormone, which causes systemic disorders and thyroid eye disease. The purpose of this study is to investigate the efficacy and safety of allogeneic anti-CD19 CAR-T for refractory Graves' disease.
The participants with refractory Graves' disease will receive a single dose of allogeneic anti-CD19 CAR-T and be regularly seen for the change of serum TRab, FT3, FT4 and clinical presentations, as well as any adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Biological: Allogeneic CAR-T |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects with refractory Graves disease, which is defined as meeting any one of the following criteria: a. Failure to discontinue medication after continuous standard antithyroid therapy for ≥ 3 years; b. Hyperthyroid state requiring medication after receiving ≥ 2 times of radioiodine therapy (with the last dose of radioiodine administered at least 6 months prior); c. Relapse ≥ 2 times after cessation of medication upon meeting the criteria for treatment discontinuation.
- Serum TRAb ≥ 3 times greater than normal range (≥ 5 IU/L)
- Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.
- Participation in this clinical study is willing to sign an informed consent with good compliance with treatment and follow-up.
- (Criteria for treatment discontinuation is define as receiving continuous anti-thyroid drug therapy for ≥18 months, and maintaining euthyroid status for ≥6 months, plus negative TRAb and TSI. Relapse is defined as recurrence of hyperthyroidism and positive TRAb/TSI after meeting the criteria for treatment discontinuation and stopping medication.)
Key exclusion criteria (16 listed)
- History of severe drug allergies or allergic constitution;
- Presence or suspicion of uncontrolled infections requiring intravenous treatment (fungal, bacterial, viral or other);
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic CAR-TThe participants will receive one dose of allogeneic CAR-T | Biological | Intervention Arm |
Primary outcome
Remission of Graves disease
Time frame: From baseline to 12 months after infusion of CAR-T cells
Sustained euthyroid status without anti-thyroid medication for ≥3 months
Incidence of Adverse Events
Time frame: From baseline to 6 months after infusion of CAR-T cells
Assessed using the CTCAE v5.0 standards
7 secondary outcomes
Anti-Thyrotropin receptor antibody (TRAb)
Time frame: From baseline to 12 months after infusion of CAR-T cells
Thyroid stimulating immunoglobulin (TSI)
Time frame: From baseline to 12 months after infusion of CAR-T cells
thyroid peroxidase antibody (TPOAb)
Time frame: From baseline to 12 months after infusion of CAR-T cells
Thyroglobulin antibody (TgAb)
Time frame: From baseline to 12 months after infusion of CAR-T cells
Thyroid volume
Time frame: From baseline to 12 months after infusion of CAR-T cells
PK parameters - CAR gene copy number
Time frame: From baseline to 3 months after infusion of CAR-T cells
PK parameters - CAR-T cell count
Time frame: From baseline to 3 months after infusion of CAR-T cells
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoying LI, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allogeneic CAR-T in people with Graves Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing JIANG, MD, PhD (86-021-64041990, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of Graves disease (time frame: From baseline to 12 months after infusion of CAR-T cells). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.