A Clinical Study for the Safety and Efficacy of CD19-CAR-DNT Cells (RJMty19) in the Treatment of Relapsed or Refractory Autoimmune Diseases
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
• Voluntarily sign an ICF and expect to complete the study procedures for follow-up examinations and treatment;
• Aged 18 to 75 years (including cut-offs), regardless of gender;
• Appropriate organ function, and accordance with the following criteria within 7 days prior to lymphodepleting chemotherapy:
• Coagulation function: a) Fibrinogen ≥1.0 g/L; b) Activated partial thromboplastin time ≤1.5 times the upper limit of normal (ULN); c) Prothrombin time (PT) ≤1.5 times ULN;
• Liver function: a) Glutathione aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); b) Glutamic aminotransferase (ALT) ≤ 3 times ULN; c) Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome. Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 1.5 times ULN may be included;
• Renal function: serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min (see Appendix 2 for Cockcroft-Gault formula);
• Complete blood count: a) Hemoglobin ≥ 80 g/L or hemoglobin maintained at that level following transfusion; b) absolute neutrophil count (ANC) ≥ 1.0×10\^9/L; c) A platelet count ≥ 30 x 10\^9/L or a platelet count maintained at that level following a platelet transfusion;
• Cardiopulmonary function: left ventricular ejection fraction (LVEF) ≥45%;
• Female patients with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female patients without childbearing potential (meeting at least 1 of the following criteria) is described below:
‣ Have undergone a hysterectomy or bilateral oophorectomy;
⁃ Medically recognized as ovarian failure;
⁃ Medically recognized as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause);
• Meets the criteria of relapsed/refractory autoimmune diseases in 2022 EULAR/ACR.