Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease
ConditionGraves Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Zhongshan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Single group
Treatments tested in this trial
Allogeneic CAR-T
Biological/VaccineThe participants will receive one dose of allogeneic CAR-T
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Remission of Graves disease
Sustained euthyroid status without anti-thyroid medication for ≥3 months
Time frame
From baseline to 12 months after infusion of CAR-T cells2
Incidence of Adverse Events
Assessed using the CTCAE v5.0 standards
Time frame
From baseline to 6 months after infusion of CAR-T cellsSecondary outcomes
1
Anti-Thyrotropin receptor antibody (TRAb)
Serum TRAb titers at 6 months and 12 months after infusion of CAR-T cells
Time frame
From baseline to 12 months after infusion of CAR-T cells2
Thyroid stimulating immunoglobulin (TSI)
Serum TSI titers at 6 months and 12 months after infusion of CAR-T cells
Time frame
From baseline to 12 months after infusion of CAR-T cells3
thyroid peroxidase antibody (TPOAb)
Serum TPOAb titers at 6 months and 12 months after infusion of CAR-T cells
Time frame
From baseline to 12 months after infusion of CAR-T cells4
Thyroglobulin antibody (TgAb)
Serum TgAb titers at 6 months and 12 months after infusion of CAR-T cells
Time frame
From baseline to 12 months after infusion of CAR-T cellsSponsors and contacts
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Source ClinicalTrials.gov