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.
Inclusion Criteria:
Exclusion Criteria:
Any change in therapy within 90 days prior to the planned administration of CAR-T cell therapy.
Patient requiring renal replacement therapy.
Active hepatitis B or active hepatitis C (HCV RNA positive).
HIV-infected patients.
Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., positive blood culture ≤ 72 hours before infusion).
Unstable angina and/or myocardial infarction within 6 months prior to screening.
Previous or concomitant malignancy with the exception of:
Pregnant and lactating women.
Intolerance to the excipients of the cell product.
Cardiac arrhythmia not controlled by medical therapy.
Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis).
The presence of any primary immunodeficiency.
Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with the protocol requirements for treatment and follow-up.
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Lyasny, Minsk Oblast 223040, Belarus
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