Safety and Efficacy of Universal CAR-T Cells (UWD-CD19) Combined with Immunosuppressants in the Treatment of Refractory Autoimmune Diseases

Sponsor
Peking University Third Hospital
Study ID
NCT06821659
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • ANCA Associated Vasculitis (AAV)
  • Inflammatory Myopathies
  • Sjogren Syndrome
  • Systemic Lupus Erthematosus
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • anti-CD19 CAR-T cells — BIOLOGICAL
    UWD-CD19

Study Details

Autoimmune diseases refer to a common category of diseases caused by the immune system reacting to self-antigens, leading to tissue damage. Autoimmune diseases encompass a wide variety of conditions, such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis. Current treatments for autoimmune diseases include glucocorticoid, immunosuppressants, and biologics. B cell-driven humoral immune abnormalities are a central pathogenic mechanism in many autoimmune diseases. When autoreactive B cells are excessively activated, they produce large amounts of autoantibodies and immune complexes. These antibodies and immune complexes can cause damage to various tissues and organs, leading to the development of multiple autoimmune diseases. Therefore, targeting B cells to treat autoimmune diseases is an attractive therapeutic strategy. Clinical studies are exploring the use of CD19-targeting CAR-T cells for the treatment of autoimmune diseases, and their therapeutic efficacy has been demonstrated. In this study, we investigate the safety and efficacy of universal CD19-targeting CAR T cells in the treatment of autoimmune diseases.

Key Dates

Start date
Mar 1, 2025
Status verified
Feb 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: anti-CD19 CAR-T (UWD-CD19)

Primary Outcome Measure

Evaluate the safety of UWD-CD19 cell injection in the treatment of refractory autoimmune diseases. [ Time Frame: 0-6 months ]

Central Contacts

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