IM19 CAR-T Cell Therapy in Refractory Systemic Lupus Erythematosus (SLE)

Inclusion Criteria:

• 1)The subject was diagnosed with systemic lupus erythematosus and met theclassification criteria of EULAR/ACR 2019 SLE (see Annex 2)

2. Age ≥ 18 years old, ≤ 65 years old

3. Weight ≥ 40 kg

4. Meets the current clinical standards for refractory systemic lupuserythematosus: the disease remains active or relapses and progresses aftersystemic treatment using the current standard treatment regimen, includingsteroids (sufficient or shock therapy), immunosuppressants (cyclophosphamide ormycophenolate mofetil), and biologics (belizumab or Rituximab)

5. Currently, one or more of the following stable dose standard therapies arebeing used to treat SLE: steroids, antimalarial drugs, immunosuppressants. Ifthe subject is receiving steroids, the following conditions must be met: atscreening time and during screening period, the maximum dose of steroids is 30mg/day prednisone (or equivalent dose). Before screening, the dose ofsteroids should remain stable for ≥ 7 days. During the screening period, thedose of steroids adjustment should not exceed 5mg/day prednisone (or equivalentdose). If the subject is receiving treatment with antimalarial drugs and/orconventional immunosuppressants: the start time of drug treatment must be ≥ 12weeks before screening. Maintain a stable dose of medication for at least 8weeks before and during screening. Before the screening period, if biologicalagents (such as belizumab or Telitacicept) are used, they need to bediscontinued for at least 4 weeks before screening.

6. Disease activity score (SLEDAI-2K) with a score of 10 or above (refer toAttachment 3)

7. Women of childbearing age who tested negative for blood pregnancy before thestart of the trial and agreed to take effective contraceptive measures duringthe trial period until the last follow-up

8. Male participants whose partners have fertility agree to take effectivecontraceptive measures during the trial period until the last follow-up

9. Those who voluntarily participate in this experiment and sign an informedconsent form.

Exclusion Criteria:

1. After evaluation by researchers, it is determined that the subject has diseasesthat are not suitable for participation in this study, such as life-threateningconditions (e.g., catastrophic antiphospholipid syndrome, acute severe renalfailure, acute severe central nervous system disease manifestations).

2. The research subject has a history of alcohol or drug abuse within the past 24weeks.

3. The research subject has a history of malignant tumors other than B-celllymphoma.

4. Major surgery (including joint surgery) was performed within 24 weeks prior toscreening, or surgery is planned within 24 weeks after enrollment in the study.

5. The research subject has overlapping mixed connective tissue diseases and othersyndromes that affect the judgment of disease activity.

6. The research subject has human immunodeficiency virus (HIV) infection,selective IgA deficiency, T-cell deficiency virus infection, chronic hepatitisB or C virus infection, or SARS-CoV-2 [severe acute respiratory syndromecoronavirus 2] infections.

7. The research subject has a known active tuberculosis (TB) infection orbacterial infection.

8. History of myocardial infarction, cardiac angioplasty or stent placement,unstable angina, active arrhythmia, or other clinically significant heartdisease within 6 months prior to screening initiation.

9. History of symptomatic deep vein thrombosis or pulmonary embolism within 6months prior to screening initiation.

10. The research subject's alanine aminotransferase (ALT), aspartateaminotransferase (AST), or alkaline phosphatase (ALP) levels are ≥3×ULN, orbilirubin >1.5×ULN, excluding laboratory test abnormalities due to SLEhepatitis.

11. The research subject has stage 4 chronic kidney failure, indicated by anestimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m², or serumcreatinine >2.5 mg/dL. During the screening visit (V1), the research subjectpresents with any of the following significant hematological abnormalities: a.Hemoglobin <7.0 g/dL b. CD4+ T lymphocytes <200/mm³ c. Absolute neutrophilcount <500/mm³ d. CD4+ T lymphocytes <500/mm³ with a neutrophil count <1000/mm³e. Platelets <25,000/mm³.

12. Treatment with CD20 monoclonal antibodies was used within the past 6 months.

13. Conditions that the researcher considers unsuitable for inclusion in thisclinical trial.