Clinical Trials

Main Inclusion Criteria:

- Recipient age ≥18 years.

- Donor age ≥18 and ≤60 years at time of signing informed consent.

- Recipients of a first or second living donor kidney transplant

- Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and
meet all local standard eligibility criteria to donate stem cells for allogeneic
transplantation.

- Recipient meets all local standard eligibility criteria for allogeneic stem cell
transplant.

- Donors must be deemed eligible as per the requirements of 21CFR1271.

Main Recipient and Donor Exclusion Criteria:

- Recipient and donor who are identical twins.

- Recipient or donor with history of malignancy or premalignant syndrome (e.g.,
myelodysplastic syndrome, monoclonal gammopathy of renal significance [MGRS],
monoclonal gammopathy of unknown significance [MGUS]) of any organ system (other than
localized basal cell carcinoma 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.

- Recipient or donor with known bone marrow aplasia.

Main Recipient-only Exclusion Criteria:

- Multi-organ or stem cell transplant recipient.

- Calculated panel reactive antibodies >80%.

- Recipient is blood type ABO incompatible with donor.

- Presence of donor-specific antibodies (DSA) (positive result) at any time
pre-transplant.

- Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg) or hepatitis C virus (HCV) positive.

- Recipient with any baseline condition requiring or anticipated will require chronic or
intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma)
throughout the course of the study.

- Recipient with a BMI < 18 or > 35 kg/m2.

- Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders,
deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted
which would preclude renal biopsy.

Main Donor-only Exclusion Criteria:

- Biologically unrelated (i.e., no genetic relationship) female donor transplant to male
recipient.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.