Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus

Inclusion Criteria:

1. A confirmed diagnosis of SLE according to the 2019 EULAR/ACR criteria.
2. Subacute or acute SLE.
3. SLE activity according to the SELENA-SLEDAI disease activity index screening score ≥6 and/or the requirement for prednisolone (or equivalent doses of methylprednisolone) at a dose greater than 7.5 mg/day (6 mg/day for methylprednisolone) to maintain lower disease activity.
4. A history of two or more prior therapies (one of the drugs mycophenolate mofetil or cyclophosphamide, or the development of side effects/intolerance to these drugs).
5. Patients aged 18 years or older.
6. A medical consultation on the need for this treatment method using cell therapy.
7. Written informed consent from the patient for treatment.
8. Patient compliance with the treatment protocol.
9. Adequate organ function.

Exclusion Criteria:

1. Any change in therapy within 90 days prior to the planned administration of CAR-T cell therapy.
2. Patient requiring renal replacement therapy.
3. Active hepatitis B or active hepatitis C (HCV RNA positive).
4. HIV-infected patients.
5. Uncontrolled acute life-threatening bacterial, viral, or fungal infection (e.g., positive blood culture ≤ 72 hours before infusion).
6. Unstable angina and/or myocardial infarction within 6 months prior to screening.

7. Previous or concomitant malignancy with the exception of:

   • basal cell or squamous cell carcinoma (adequate wound healing is required before study entry);
   • In situ carcinoma of the cervix or breast, without evidence of recurrence for at least 3 years prior to study entry;
   • A primary malignant tumor that has been completely resected and in complete remission for ≥ 5 years.
8. Pregnant and lactating women.
9. Intolerance to the excipients of the cell product.
10. Cardiac arrhythmia not controlled by medical therapy.
11. Patients with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis).
12. The presence of any primary immunodeficiency.

13. Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with the protocol requirements for treatment and follow-up.

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