A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients

Exclusion Criteria

• •1. Donor/recipient crossmatch positive at time of living donor kidney transplantation.
• •2. Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
• •3. Recipient or donor with history of hypersensitivity to any of the study drugs or drugs of similar chemical classes.
• •4. Recipient and donor who are identical twins.
• •5. Pregnant or nursing (lactating) woman.
• •6. Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance \[MGRS\], monoclonal gammopathy of unknown significant \[MGUS\]) of any organ system (other than localized excised non-melanomatous lesions of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• •7. Recipient or donor with known bone marrow aplasia.
• •8. Multi-organ or cell transplant recipient.
• •9. Blood type ABO incompatible with donor.
• •10. Positive donor-specific antibody (DSA) at any time pre- or post-transplant (to be confirmed within 30 days prior to FCR001 infusion).
• •11. Panel Reactive Antibodies (PRA) \>80% at the time of living donor kidney transplantation.
• •12. Induction with alemtuzumab at the time of living donor kidney transplantation.
• •13. History of acute rejection (biopsy-proven or suspected and treated) or recurrent kidney disease following living donor kidney transplantation.
• •14. Findings consistent with acute rejection or recurrent disease on the Screening biopsy.
• •15. Demonstrated intolerance to maintenance immunosuppression with tacrolimus and MMF or MPS.
• •16. Being maintained on oral corticosteroids (prednisone \>10 mg/day or equivalent).
• •17. Positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Recipients with history of HCV infection may participate if there is a documented history of treatment with an anti-HCV agent and either one (1) documented negative PCR at least three (3) months after last dose of treatment, or two (2) documented negative PCRs at least 2 weeks apart over a maximum of 4 weeks.
• •18. Positive for BKV, CMV, or EBV by PCR at screening.
• •19. Having any baseline condition requiring or anticipated to require chronic or intermittent use of systemic steroids or other IS (e.g., autoimmune disease, asthma) throughout the course of the study.
• •20. Having a body mass index (BMI) \< 18 or \> 35 kg/m\^2.
• •21. Requiring systemic anticoagulation, (e.g., for hypercoagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted with would preclude renal biopsy.
• •22. Having contraindication to TBI according to local radiologist.
• •23. History of autologous or allogeneic hematopoietic progenitor or mesenchymal stem cell transplant prior to signing informed consent.
• •24. Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.