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

Inclusion Criteria:

1. Written informed consent.
2. Male or female aged 18 - 70 years.
3. Diagnosis of End Stage Renal Disease and waiting for a new kidney from an identified live donor.
4. Subjects who will be single organ recipients (kidney).
5. Able and willing to use contraception.

Exclusion Criteria:

1. HLA identical to the donor.
2. Subjects with prior organ transplant.
3. Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug.
4. 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.
5. Subjects who are Epstein-Barr Virus (EBV) seronegative.
6. Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
7. Subjects with panel-reactive antibody (PRA) >20% within 6 months prior to enrolment.
8. Subjects with current or recent donor-specific antibodies.
9. Use of any experimental medicinal product within 3 months.
10. Current use of systemic immunosuppressive agents
11. 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.
12. Subjects with abnormal laboratory values in the following parameters:
13. Haemoglobin
14. Platelets
15. White blood cells
16. Aspartate transaminase (AST) and or alanine transaminase (ALT)
17. Total bilirubin