רדאר ניסויים קליניים

voluntarily sign the informed consent form (ICF): I fully understand and know this study and sign the informed consent form. I am willing to follow and be able to complete all research procedures;

when signing ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender;

no systemic active infection (such as infectious pneumonia and tuberculosis) within 2 weeks before screening;

women with fertility (defined as all women who are physically able to conceive) must agree to use efficient contraceptive methods from at least 28 days before the start of gonorrhea to 1 year after ct1195e infusion, and it is absolutely prohibited to donate eggs within 1 year after receiving study treatment infusion during the study period. Men whose partners are fertile must agree to use effective barrier contraception from the beginning of gonorrhea to 1 year after ct1195e infusion, and should not donate semen or sperm during the entire study period;

women with fertility must be tested negative for serum β human chorionic gonadotropin (β -hcg) at the time of screening and within 48 hours before gonorrhea treatment.

meet the 2013 eular/acr classification criteria for systemic sclerosis, and meet the diffuse manifestations, and the disease duration is ≤ 7 years (the onset time of the disease duration is defined as the time of the initial diagnosis of SSC);

complicated with interstitial pneumonia, that is, the interstitial changes of ground glass exudation suggested by chest HRCT;

meet the following definitions of refractory or progressive disease:

1. Definition of refractory: the conventional treatment for more than 6 months is still ineffective, or the disease relapses after remission. Definition of conventional treatment: use of glucocorticoids (more than 1 mg/kg/d) or cyclophosphamide, as well as one or more of the following immunomodulatory drugs: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents, including yamerol, rituximab, belizumab, etanercept, etc;

2. According to the definition of progressiveness, 2 of the following three items can be met in the past 1 year (within the past 1 year):

   1. Aggravation of symptoms;
   2. FVC estimated value decreases by 5%, or DLCO estimated value decreases by 10%;
   3. Pulmonary imaging aggravated;

important organ functions:

1. Renal function: defined as creatinine clearance (Cockcroft Gault) ≥ 50 ml/min calculated without hydration assistance;
2. Bone marrow function: defined as neutrophil (ANC) ≥ 1.0 × 109/l, hemoglobin (HB) ≥ 90 g/l. Blood transfusion and growth factors shall not be used to meet the above requirements within 7 days before the eligibility screening;
3. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN), total bilirubin ≤ 2 × upper limit of normal (ULN)
4. Coagulation function: INR ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
5. Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥ 40%.