Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus
NCT07720310 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 12
Last updated 2026-07-22
Summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by B-cell dysfunction leading to the production of autoantibodies that play a key role in the onset and progression of the disease. In the treatment of SLE today, glucocorticosteroid hormones, cytostatics (azathioprine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, etc.), and biological therapy (rituximab, belimumab) are widely used. However, this therapy has limitations: firstly, it does not always control the autoimmune process and, secondly, it has side effects. Recent global data on the use of CAR T cells in patients with SLE show promising results, including rapid and durable remission, without the need for disease-modifying drugs and glucocorticoids. The use of the so-called academic CAR-T cell products can improve availability and affordability of this therapy option. The aim of this clinical study is to evaluate the efficacy and safety of academic CAR-T cells in refractory SLE patients.
Conditions
- System Lupus Erythematosus(SLE)
Interventions
- BIOLOGICAL
-
CAR T cells chimeric antigen receptor cells
academical CAR-T product was manufactured using lentiviral vector encoding anti-CD19 CAR.
Sponsors & Collaborators
-
Minsk scientific and practical center of surgery, transplantology and hematology
collaborator UNKNOWN -
N.N. Alexandrov National Cancer Centre
lead OTHER_GOV
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-09
- Primary Completion
- 2028-06-30
- Completion
- 2030-06-30
Countries
- Belarus
Study Locations
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