Graves' DiseaseEarly Phase 1NCT07261345
Allogeneic Anti-CD19/BCMA CAR-T for Refractory Graves' Disease
A Early Phase 1 study testing allogenic anti-CD19/BCMA CAR-T in people with Graves' Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- allogenic anti-CD19/BCMA CAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2025to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
HUIJIE ZHANG, MD, PhD
About this study
Official title: The Safety and Efficacy of Allogenic Anti-CD19/BCMA CAR-T Cell Therapy for Refractory Graves' Disease
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.
- Conditions
- Graves' Disease
- Being tested
- allogenic anti-CD19/BCMA CAR-T
- Keywords
- CAR-T, TSH receptor antibody, refractory Graves' disease
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogenic anti-CD19/BCMA CAR-TBiological
Participants will receive a single infusion of allogenic anti-CD19/BCMA CAR-T (RD06-05).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will receive a single dose of allogenic anti-CD19/BCMA CAR-T (RD06-05). Receives: Biological: allogenic anti-CD19/BCMA CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (AEs)
Measured: From baseline to 12 months after infusion of CAR-T cells
Remission of Graves' disease
Proportion of remission will be calculated throughout 12 months after infusion of CAR-T cells. Remission is defined as euthyroid status without anti-thyroid medication.
Measured: From baseline to 12 months after infusion of CAR-T cells
Secondary outcomes (17)
Proportion of participants with ≥50% reduction of anti-thyrotropin receptor antibody (TRAb)
Percentage of participants achieving a ≥50% reduction of TRAb throughout 12 months after infusion of CAR-T, as compared with baseline.
Measured: From baseline to 12 months after infusion of CAR-T cells
Proportion of participants with ≥50% reduction of thyroid stimulating immunoglobulin (TSI)
Percentage of participants achieving a ≥50% reduction of TSI throughout 12 months after infusion of CAR-T, as compared with baseline.
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of TRAb levels compared to baseline
TRAb levels will be measured from baseline to 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of TSI levels compared to baseline
TSI levels will be measured from baseline to 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of thyroid gland volume compared to baseline
Size of the thyroid will be measured and calculated by ultrasound from baseline to 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of thyroid peroxidase antibody (TPOAb) levels compared to baseline
TPOAb levels will be measured from baseline to 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of thyroglobulin antibody (TgAb) levels compared to baseline
TgAb levels will be measured from baseline to 12 months after infusion of CAR-T cells.
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of serum free T3 (FT3) levels compared to baseline
FT3 levels will be measured from baseline to 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Change of serum free T4 (FT4) levels compared to baseline
FT4 levels will be measured from baseline to 12 months after infusion of CAR-T cells
Measured: From baseline to 12 months after infusion of CAR-T cells
Cmax of CAR-T cells after infusion
Peak peripheral blood concentration of CAR-T cells (RD06-05 ) following infusion, measured by flow cytometry.
Measured: Day 0 to Day 28
Tmax of CAR-T cells after infusion
Time to reach maximum observed concentration (Tmax) of CAR-T cells (RD06-05).
Measured: Day 0 to Day 28
Dynamic change of circulating CAR-T cell count
Measured: From baseline to 3 months after infusion
Dynamic change of CAR transgene copy number
Measured: From baseline to 3 months after infusion
Dynamic change of peripheral B lymphocyte cell counts
Measured: From baseline to 12 months after infusion of CAR-T cells.
Dynamic change of serum interleukin-6
Measured: From baseline to 3 months after infusion of CAR-T cells.
Dynamic change of serum tumor necrosis factor α (TNF-α)
Measured: From baseline to 3 months after infusion of CAR-T cells.
Dynamic change of serum immunoglobulin levels
Measured: From baseline to 12 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start19 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 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
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261345
- Sponsor's protocol ID
- B2025-711
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Allogenic Anti-CD19/BCMA CAR-T Cell Therapy for Refractory Graves' Disease
- ClinicalTrials.gov ID
- NCT07261345
- Acronym / sponsor ID
- B2025-711
- Conditions
- Graves' Disease
- Keywords
- CAR-T, TSH receptor antibody, refractory Graves' disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Dec 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 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.
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: allogenic anti-CD19/BCMA CAR-TParticipants will receive a single dose of allogenic anti-CD19/BCMA CAR-T (RD06-05). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| allogenic anti-CD19/BCMA CAR-TParticipants will receive a single infusion of allogenic anti-CD19/BCMA CAR-T (RD06-05). | Biological | Intervention Arm |
Primary outcome
Incidence and severity of treatment-emergent adverse events (AEs)
Time frame: From baseline to 12 months after infusion of CAR-T cells
Remission of Graves' disease
Time frame: From baseline to 12 months after infusion of CAR-T cells
Proportion of remission will be calculated throughout 12 months after infusion of CAR-T cells. Remission is defined as euthyroid status without anti-thyroid medication.
17 secondary outcomes
Proportion of participants with ≥50% reduction of anti-thyrotropin receptor antibody (TRAb)
Time frame: From baseline to 12 months after infusion of CAR-T cells
Proportion of participants with ≥50% reduction of thyroid stimulating immunoglobulin (TSI)
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of TRAb levels compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of TSI levels compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of thyroid gland volume compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of thyroid peroxidase antibody (TPOAb) levels compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of thyroglobulin antibody (TgAb) levels compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of serum free T3 (FT3) levels compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Change of serum free T4 (FT4) levels compared to baseline
Time frame: From baseline to 12 months after infusion of CAR-T cells
Cmax of CAR-T cells after infusion
Time frame: Day 0 to Day 28
Tmax of CAR-T cells after infusion
Time frame: Day 0 to Day 28
Dynamic change of circulating CAR-T cell count
Time frame: From baseline to 3 months after infusion
Dynamic change of CAR transgene copy number
Time frame: From baseline to 3 months after infusion
Dynamic change of peripheral B lymphocyte cell counts
Time frame: From baseline to 12 months after infusion of CAR-T cells.
Dynamic change of serum interleukin-6
Time frame: From baseline to 3 months after infusion of CAR-T cells.
Dynamic change of serum tumor necrosis factor α (TNF-α)
Time frame: From baseline to 3 months after infusion of CAR-T cells.
Dynamic change of serum immunoglobulin levels
Time frame: From baseline to 12 months after infusion
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 5 Jan 2026.
- 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.
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 allogenic anti-CD19/BCMA 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?
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 5 Jan 2026. 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?
Incidence and severity of treatment-emergent adverse events (AEs) (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 5 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.