This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis
Trial Parameters
Brief Summary
This is an early exploratory study to assess the tolerability and safety of GC012F CAR T cell injection in Multiple Sclerosis patients.
Eligibility Criteria
Inclusion Criteria: * 1\. The laboratory test results at screening must meet the following criteria: * a)Absolute neutrophil count ≥ 1.0 × 10\^9/L (no growth factor is given for supportive care within 7 days prior to testing); * b)Absolute lymphocyte count ≥ 1.0×10\^9/L; * c)Hemoglobin ≥ 80 g/L (no red blood cell transfusion is given within 7 days prior to testing); * d)Platelet count ≥ 50×10\^9/L (no blood transfusion is given within 7 days prior to testing); * e)Serum IgG ≥ 500 mg/dL; * f)Activated partial thromboplastin time ≤ 1.5 × upper limit of normal (ULN), prothrombin time (PT) ≤ 1.5 × ULN; * g)Adequate renal, hepatic, cardiopulmonary function : i.Serum alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN; ii.Total bilirubin \< 2 × ULN (direct bilirubin ≤ 1.5 × ULN for subjects with Gilbert's syndrome); iii.Creatinine ≤ 2 mg/dL or creatinine clearance ≥ 60 mL/min (estimated according to the Cockcroft Gault formula); iv.Subjects with left ventricular ejection fracti