Safety and Preliminary Clinical Activity of Itolizumab in ARDS

Exclusion Criteria

• •1. ARDS caused by non-infectious pneumonia (e.g., burns, drowning, poisoning, etc.)
• •2. Subject who has cardiogenic pulmonary edema, and it is the main cause of respiratory failure
• •3. Subject who is at high risk of death within 24 hours regardless of the treatment measures given as determined by the investigator
• •4. Subject who is receiving extracorporeal membrane pulmonary oxygenation (ECMO) therapy at the time of screening.
• •5. Subject who had received mechanical ventilation for more than 72 hours prior to administration.
• •6. Subject with active tumors (other than carcinoma in situ or basal cell carcinoma) that requiring treatment.
• •7. Any of the following chronic organ damage or immunosuppression:
• •1. Cardiac: cardiac arrest within 7 days prior to screening; New York Heart Association cardiac function class IV at screening;
• •2. Pulmonary: oxygen therapy or ventilator-dependent therapy for more than 1 month cumulatively within 6 months prior to screening; pulmonary embolism within 4 weeks prior to screening; pulmonary hypertension, end-stage lung disease, or interstitial lung disease requiring glucocorticoid therapy at screening;
• •3. Renal: serum creatinine \> 1.5 ULN or creatinine clearance \< 30 mL/min at screening (Cockcroft-Gault formula, see study protocol annex 5 for details) or on long-term dialysis treatment;
• •4. Liver: liver function classification of Child-Pugh grade C at screening;
• •5. Immunosuppression status: with lymphoma, leukemia or acquired immunodeficiency; having received antitumor chemotherapy in the last 3 months, or being treated with immunosuppression for organ transplantation or immune disorders; having had allogeneic bone marrow transplantation or allogeneic hematopoietic stem cell transplantation.
• •8. Subject who had vaccination within 28 days prior to administration, or plan to get the vaccine during the study period
• •9. Any of the following abnormalities at screening
• •1. Hepatitis B-related tests: ① positive for hepatitis B surface antigen (HBsAg); ② positive for hepatitis B core antibody (HBcAb); ③ positive for hepatitis B surface antibody (HBsAb) and no history of hepatitis B vaccination; ④ positive for hepatitis B e antigen or hepatitis B e antibody;
• •2. Positive hepatitis C virus antibody (HCV-Ab);
• •3. Positive acquired immunodeficiency syndrome antibody (HIV-Ab).
• •10. Subject who has a medical history of tuberculosis or those who deny a history of tuberculosis but has a positive gamma-interferon release test at screening.
• •11. Absolute lymphocyte count \< 0.2×109/L at screening
• •12. Suspected allergic to the investigational drug or any of its excipients
• •13. Currently pregnant, breastfeeding,or planning to become pregnant or not using reliable method to avoid pregnancy during study and within 3 months after the last study treatment
• •14. Subject who had participated in other clinical studies (other than those not receiving interventions, such as observational study or questionnaires survey) within 3 months prior to screening, or who are participating in other experimental treatments.
• •15. As determined by the investigator, any medical, psychiatric, or other condition or circumstance that is likely to negatively affect the reliability of the study data.