Universal CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus

This investigator-initiated trial aims to evaluate the safety and efficacy of CHT101 in patients with relapsed refractory systemic lupus erythematosus.

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of CHT101 in patients with relapsed refractory systemic lupus erythematosus.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE).
2. SLEDAI-2000 score \>6.
3. Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.
4. Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg/kg/day) combined with cyclophosphamide and ≥1 of the following immunosuppressants for \>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and/or biologics (e.g., rituximab, belimumab, telitacicept).
5. Aged 18-65 years; both genders eligible.
6. Adequate organ function:Bone marrow function: White blood cell count ≥3×10⁹/L. Absolute neutrophil count ≥1×10⁹/L (without colony-stimulating factor therapy within 2 weeks prior to testing). Hemoglobin ≥60 g/L; Liver function: Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤3×ULN. Total bilirubin (TBIL) ≤1.5×ULN (except Gilbert's syndrome, TBIL ≤3.0×ULN); Renal function: Creatinine clearance (CrCl) ≥60 mL/min (calculated by Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN; Cardiac function: Hemodynamic stability with left ventricular ejection fraction (LVEF) ≥55%.
7. Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. Females of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating.
8. Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.

Exclusion Criteria:

1. Presence of neuropsychiatric lupus (NPSLE).
2. History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).
3. History of severe drug allergies or hypersensitivity.
4. Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).
5. Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.
6. Severe cardiac diseases.
7. Congenital immunoglobulin deficiency.
8. History of malignancy (except non-melanoma skin cancer, in situ cervical/bladder/breast/thyroid carcinoma with disease-free survival \>5 years).
9. End-stage renal failure.
10. Participants meeting any of the following: Hepatitis B surface antigen (HBsAg)-positive or hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; Hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; HIV antibody-positive; Syphilis-positive (RPR and TPHA positive, or TPHA positive with RPR reconfirmed positive after 4 weeks).
11. Psychiatric disorders or severe cognitive impairment.
12. Participation in other clinical trials within 3 months prior to enrollment.
13. Pregnant women or those planning pregnancy.
14. Other conditions deemed by the investigator to preclude study participation.