Clinical Study on the Targeted CD19 Universal CAR-T Cell Injection (RD06-04) for the Treatment of IIM and AAV

Inclusion Criteria

• •1. The subject voluntarily participates in this trial and has signed the informed consent form.
• •2. Age ≥18 years and ≤70 years, regardless of gender.
• •3. Organ Function and Laboratory Tests:
• •1. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except for Gilbert syndrome).
• •2. Renal Function: Creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
• •3. Blood Routine: Neutrophil count ≥1×10\^9/L, hemoglobin ≥60 g/L, platelet count ≥50×10\^9/L, lymphocyte count \>0.3×10\^9/L.
• •4. Coagulation Function: International normalized ratio (INR) ≤1.5×ULN, or prothrombin time (PT) ≤1.5×ULN.
• •5. Oxygen saturation (SpO2) ≥92% at rest while breathing room air.
• •6. Echocardiography shows left ventricular ejection fraction (LVEF) ≥50%.
• •4. Female subjects of childbearing potential must have a negative serum or urine pregnancy test result during screening.
• •5. Females of childbearing potential must agree to use highly effective contraception from at least 28 days before the start of lymphodepletion until 12 months after the infusion of RD06-04. Males of reproductive potential must agree to use an effective barrier method of contraception from the start of lymphodepletion until 12 months after the infusion of RD06-04 and must not donate semen or sperm during the entire trial period.
• •For IIM participants:
• •1\. Diagnosed with IIM (including probable or definite diagnosis, i.e., a probability of ≥55%) according to the 2017 ACR/EULAR classification criteria. Currently, the ENMC considers that the subtypes of IIM mainly include dermatomyositis (DM), antisynthetase syndrome (ASS), and immune-mediated necrotizing myopathy (IMNM).
• •For AAV participants:
• •1\. Meets the diagnostic criteria for ANCA-associated vasculitis as established by the 2022 ACR/EULAR, including microscopic polyangiitis (MPA), granulomatosis with polyangiitis (GPA), and eosinophilic granulomatosis with polyangiitis (EGPA).