Multiple Sclerosis (MS) Clinical Trials

• 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 fraction ≥ 45% (performed within 8 weeks prior to apheresis) as diagnosed by echocardiography (ECHO) or multi-gated acquisition scan and no evidence of pericardial effusion as determined by ECHO and no clinically significant electrocardiographic findings; v.Baseline oxygen saturation \> 92% under indoor air conditions; vi.Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m\^2.

• 2.Confirmed diagnosis of MS based on the 2017 McDonald diagnostic criteria and diagnosis of relapsing or progressive MS based on the 2013 Lublin phenotype criteria for multiple sclerosis;

‣ Relapsing-remitting multiple sclerosis (RRMS):

• patients with RRMS who have failed ≥ 1 highly effective disease modifying therapy (DMT) (fingolimod, siponimod, ozanimod, and anti-leukocyte cluster of differentiation \[CD\] 20 monoclonal antibody therapy, etc.) (defined as at least 12 months of continuous use).

∙ At least 2 clinical relapses in the past 2 years, or 1 clinical relapse in the past 2 years with ≥ 1 new Gd-enhancing lesion on MRI, or ≥ 1 new Gd-enhancing lesion on MRI within the past 6 months; c) ≥ 2 Gd-enhancing lesions on T1-weighted brain MRI at screening.

⁃ Primary progressive multiple sclerosis (PPMS):

• patients with primary progressive MS who have failed highly effective DMT and whose disease activity has worsened recently (i.e., within 1 year) (EDSS disease progression score ≥ 0.5);

∙ no Gd-enhancing lesions on brain MRI at screening.

⁃ Secondary progressive multiple sclerosis (SPMS):

• patients with secondary progressive MS who have failed highly effective DMT and whose disease activity has worsened recently (i.e., within 1 year) (EDSS disease progression score ≥ 0.5);

∙ no Gd-enhancing lesions on brain MRI at screening.

• 3.EDSS score ≥ 2.0 and ≤ 6.5;

• 4.Documented history or confirmation at screening of the presence of oligoclonal bands or an elevated IgG index in CSF.