Inaticabtagene Autoleucel Injection in the Treatment of Refractory Systemic Lupus Erythematosus-related Immune Thrombocytopenia

Inclusion Criteria:

1. Age range: 18-70 years (including 18 and 70 years), regardless of gender.

2. Clinically diagnosed with Refractory Systemic Lupus Erythematosus-related ImmuneThrombocytopenia according to the revised criteria of ACR in 1997 or EULAR/ACR in

3. At least two consecutive blood routine tests showing platelet counts <50×10^9/L; Peripheral blood smear microscopy showed no significant abnormalities inthe morphology of blood cells; The morphological characteristics of bone marrowcells are consistent with immune thrombocytopenia. Treated at least 1 course of MPshock therapy or high-dose steroids, combined with one or more immunosuppressiveagents (including biologics) for at least 3 months but not achieving partialremission, or the efficacy cannot be maintained during the steroid reductionprocess.

4. During the study period, the use of corticosteroids at a dose not exceeding 10mgprednisone or its equivalent, all immunosuppressants (excluding hydroxychloroquine)should be discontinued.

5. Women of childbearing potential must have a negative blood pregnancy test 7 daysprior to trial conditioning therapy; any male and female patients of childbearingpotential must agree to use an effective method of contraception throughout thestudy and for at least 2 year following infusion of CAR-T cells. Childbearingpotential is biologically capable of bearing a living baby and sexually active.Female patients who were not of childbearing potential (ie, met at least 1 of thefollowing criteria):

• Hysterectomy or oophorectomy, or

• Medically confirmed ovarian failure, or medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months in the absence ofpathological or physiological causes).

5. Adequate organ function according to the following criteria:

• Aspartate aminotransferase (AST) ≤ 3 times of upper limit of normal (ULN);

• Alanine aminotransferase (ALT) ≤ 3 times ULN;

• Total serum bilirubin ≤ 2 times ULN unless the patient has documented Gilbert'ssyndrome; patients with Gilbert's syndrome who have bilirubin ≤ 3.0 times ULNand direct bilirubin ≤ 1.5 times ULN may be included;

• Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min (Cockcroft and Gault formula), Patients with lupus nephritis may relax theconditions appropriately according to the judgment of the investigator;

• Must have minimal pulmonary reserve and oxygen saturation > 91% in anonoxygenated state;

• Lymphocyte count > 0.4 × 109/L.

Exclusion Criteria:

1. Severe active central nervous system (CNS) lupus, including seizures, psychosis,cerebrovascular accidents, or CNS vasculitis requiring therapeutic interventionwithin 60 days after baseline.

2. Dialysis patients or creatinine clearance rate less than 30mL/min.

3. Pregnancy or breastfeeding.

4. Merge active infections (such as sepsis, bacteremia, mycosis, uncontrolled lunginfections, and active tuberculosis).

5. Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) arepositive; Hepatitis B e antibody (HBe Ab) and/or hepatitis B core antibody (HBcAb)are positive, and the number of HBV-DNA copies is greater than the measurable lowerlimit; Hepatitis C (HCV) antibody positive; positive for human immunodeficiencyvirus (HIV) antibodies; positive for syphilis antibody (TP Ab);

6. Major surgery that was assessed as unsuitable by the investigators within 4 weeksbefore screening.

7. Patients with concurrent active malignancy within the past five years, those with ahistory of malignancy but cuired are eligible.

8. The patient's heart meets any of the following conditions: Left ventricular ejection fraction (LVEF) ≤ 45%; New York Heart Association (NYHA)Grade III or IV congestive heart failure or active heart disease; Severe arrhythmiasthat require treatment (excluding atrial fibrillation and paroxysmalsupraventricular tachycardia); QTcB interval ≥ 450ms for males and ≥ 470ms forfemales (QTcB=QT/RR1/2); Have had myocardial infarction, bypass or stent surgerywithin the 6 months prior to the study; Other heart diseases that have beendetermined by researchers to be unsuitable for inclusion;

9. Patients with clinically significant pleural effusion during screening.

10. Patients vaccinated with a live vaccine within 6 weeks prior to screening.

11. Patients with deep vein thrombosis within 6 months prior to screening, or a historyof pulmonary embolism.

12. Patients with a life expectancy of less than 6 months.

13. Patients participating in any other interventional clinical study or receivingtreatment of an active investigational drug within 3 months or 5 half-lives forlaunched drugs prior to Inaticabtagene Autoleucel Injection infusion.

14. Patients with a history of epilepsy, cerebral ischemia/hemorrhage, cerebellardiseases, or other active central nervous system disorders;

15. Patients with hypersensitivity reactions to the components of InaticabtageneAutoleucel Injection.

16. Patients previously received CAR-T cell therapy.