Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients

Exclusion Criteria

• •Severe cardiac, respiratory disease or any other major organ dysfunction.
• •Subjects with prior non-liver solid organ or hematopoietic stem cell transplant.
• •Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug.
• •Positive serology for human immunodeficiency virus (HIV), active or latent tuberculosis (TB) or other clinically active local or systemic infection.
• •Use of investigational agents within 3 months of screening.
• •Subjects with history of autoimmune disease requiring use of immunosuppression or biologics within 24 months prior to study entry.
• •Subject with history of malignancy in the past 5 years.
• •Medical or social condition that is not compatible with adequate study follow-up and any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
• •Protocol defined laboratory value for the following parameters:
• •* Alanine aminotransferase (ALT) and either alkaline phosphatase (ALP) or gamma-glutamyl transferase (GGT),
• •* Kidney function e.g. eGFR,
• •* White blood cells,
• •* Hemoglobin,
• •* Platelets.