Allogeneic Anti-CD19 CAR-T for Refractory Graves' Disease

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07129642
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic CAR-T — BIOLOGICAL
    The participants will receive one dose of allogeneic CAR-T

Study Details

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.

Key Dates

Start date
Aug 10, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Arm

Primary Outcome Measure

Remission of Graves disease [ Time Frame: From baseline to 12 months after infusion of CAR-T cells ]

Central Contacts

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