This study aims to evaluate the safety and tolerability of SNC116 in treating patients with systemic lupus erythematosus.
Inclusion Criteria:
Age ≥ 18 years, ≤ 65 years, gender not restricted.
For refractory systemic lupus erythematosus (SLE), the following criteria must be met:
Within 7 days before SNC116 administration, the blood routine test results must meet the following requirements (excluding SLE activity caused by surgery and assessed by the investigator):
During the screening period, serum pregnancy test results of fertile female subjects must be negative (women who have undergone surgical sterilization or have been menopausal for at least 2 years are considered to have no fertility). Fertile female subjects and male subjects must use highly effective contraceptive methods throughout the clinical study and within 2 years after the last study treatment.
Subjects must agree not to donate blood, organs, tissues, sperm/spirit and/or egg cells for at least 2 years after SNC116 treatment.
Voluntarily participate in the clinical trial and sign the informed consent form.
Exclusion Criteria:
Individuals who have had any allergic reaction, hypersensitivity reaction, intolerance or contraindication to the components of SNC116 or the drugs that may be used in the study (such as tocilizumab), or who have previously experienced severe allergic reactions.
Subjects who had uncontrolled active infections requiring intravenous antibiotics, antiviral or antifungal drugs, etc. within 7 days before the administration of SNC116.
Subjects with a primary immunodeficiency disorder.
Subjects who had malignant tumors requiring treatment or evidence of recurrence within 2 years before screening (excluding: non-melanoma skin cancer that has been fully cured, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, breast duct carcinoma, thyroid cancer, and other localized carcinomas).
Subjects who have previously received any treatment using vesicular virus G glycoprotein pseudotyped viruses.
Subjects who have previously received CD19 CAR-T cell therapy or other genetically modified T cell therapy.
Subjects with organ dysfunction, meeting any of the following criteria:
Subjects with clinically significant major cardiovascular diseases, including any of the following:
Meet any of the following criteria:
Subjects who had a history of or symptoms of severe central nervous system diseases within 6 months before screening (excluding simple trigeminal nerve disease; except for those caused by SLE activity, as assessed by the investigator). These include but are not limited to mental disorders, cerebrovascular diseases, encephalitis, brain injury, epilepsy, convulsions, aphasia, dementia, suicidal tendencies, etc. 11. Before receiving SNC116, the following drugs/treatments were administered:
12. Had other active autoimmune diseases and the investigator determined that they were not suitable to participate in this study.
13. Pregnant, or lactating, or planning to become pregnant. 14. Had other serious or diagnosed medical conditions within 3 months before screening (such as severe pulmonary disease or oxygen-dependent dependence, or progressive renal function deterioration requiring dialysis treatment, or active gastrointestinal bleeding/ulcer/perforation, or uncontrolled serous cavity effusion, etc.), and the investigator believed that these conditions might affect the safety or study compliance of the subjects, and were not suitable to participate in this study.
15. Exclusion criteria for SLE:
a) Diagnosed as drug-induced lupus; b) At screening, had lupus crisis, or severe central nervous system involvement (neuro-psychiatric lupus) of the subjects.
16. Other situations that the investigator believed might affect the safety or study compliance of the subjects and were not suitable to participate in the study.
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intravenous administration
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