CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)

6. Adequate organ function:

o Renal function: Defined as a calculated creatinine clearance rate (Cockcroft - Gault) ≥ 50 mL/min without the need for hydration assistance.

o Bone marrow function: Defined as absolute neutrophil count (ANC) ≥ 1.0×10⁹/L and hemoglobin (Hb) ≥ 60 g/L. Blood transfusion and growth factors should not be used to meet these requirements within 7 days before the inclusion and exclusion screening.

o Liver function: Defined as alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2× the upper limit of normal (ULN), and total bilirubin ≤ 2× the upper limit of normal (ULN).

o Coagulation function: Defined as international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN.

o Lung function: Oxygen saturation (SpO₂) ≥ 92% (measured by pulse oximeter) in room air.

* Cardiac function: Defined as a left ventricular ejection fraction (LVEF) ≥ 40% as evaluated by echocardiogram (ECHO) within 8 weeks before screening.

1. Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.

2. Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.

3. Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.

4. Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.

5. Use of immunosuppressive agents that affect T-cells (mycophenolate mofetil, methotrexate, cyclosporine, azathioprine, leflunomide, tacrolimus) within 10 days before the infusion of CT1190B.

6. Use of JAK inhibitors (tofacitinib, baricitinib tablets, ruxolitinib, etc.) within 3 days before the infusion of CT1190B.

7. Vaccination with live-attenuated vaccines, inactivated vaccines, or RNA vaccines within 1 month before screening.

8. Diagnosis of cancer within 2 years before signing the ICF. Exceptions include non-melanoma skin cancer treated by radical therapy, local prostate cancer, biopsy-proven cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smear, and completely resected breast carcinoma in situ.

9. Undergoing major surgery within 4 weeks before signing the ICF, or planning to undergo major surgery during the study, and the investigator deems it will pose an unacceptable risk to the participant.

10. Positive test for HIV, syphilis, active hepatitis B virus infection, or active hepatitis C virus infection at screening.

11. History of central nervous system diseases before screening, including but not limited to cerebrovascular accident, encephalitis, epilepsy, convulsions/seizures, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar diseases, central nervous system vasculitis, cognitive impairment, organic brain syndrome, or mental illness.

12. History of any of the following cardiovascular diseases within 1 month before screening: Heart failure of class III or IV as defined by the New York Heart Association (NYHA), myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other heart diseases of significant clinical significance.

13. Participation in other clinical studies within 3 months before screening or still within five half-lives after the last dose of the drug.

14. Current presence of any uncontrolled active infection, including but not limited to active tuberculosis, etc.

15. History or evidence of suicidal thoughts within 6 months before signing the ICF, or any suicidal behavior within the previous 12 months, and the investigator deems there is a significant suicide risk.

16. Pregnant or breastfeeding women.

17. Poor compliance judged by the investigator, inability or unwillingness to comply with the requirements of the study protocol, or other reasons that make the participant unsuitable for this clinical study.

1. Severe lupus nephritis within 2 months before screening, requiring hemodialysis, or receiving prednisone ≥ 100 mg/d or equivalent corticosteroid treatment for ≥ 14 days.

2. Lupus crisis within 1 month before screening, and the investigator deems it inappropriate for the participant to participate in this study.

3. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, impaired intellectual function, visual impairment, etc.

4. History of ≥ grade 2 bleeding within 30 days before screening.

5. Plasmapheresis, plasma separation, or hemodialysis within 14 days before screening.

1\. FVC ≤ 30% of the predicted value or DLCO (corrected for hemoglobin) ≤ 30% of the predicted value.

2\. Combined with severe kidney disease or signs of renal crisis in the participant.

3\. Risk of active tuberculosis at screening.

What this study is about