Safety & Tolerability Study of Chimeric Antigen Receptor T-Reg Cell Therapy in Living Donor Renal Transplant Recipients

Exclusion Criteria

• •HLA identical to the donor.
• •Subjects with prior organ 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) or syphilis, active or occult hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, or other clinically active local or systemic infection.
• •Subjects who are Epstein-Barr Virus (EBV) seronegative.
• •Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
• •Subjects with panel-reactive antibody (PRA) \>20% within 6 months prior to enrolment.
• •Subjects with current or recent donor-specific antibodies.
• •Use of any experimental medicinal product within 3 months.
• •Current use of systemic immunosuppressive agents
• •Significant unstable or poorly controlled acute or chronic diseases (except ESRD), limited life expectancy, clinically relevant central nervous system pathology, history of drug/alcohol abuse or psychiatric disorder or other condition that is not compatible with adequate study follow-up, history of malignancy in the past 5 years 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.
• •Subjects with abnormal laboratory values in the following parameters:
• •Haemoglobin
• •Platelets
• •White blood cells
• •Aspartate transaminase (AST) and or alanine transaminase (ALT)
• •Total bilirubin