Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

FCR001A2201

An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.

2008-03-01

2023-03-01

2023-04-01

Terminated

Early phase I

37

Inclusion Criteria: * Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure * Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation * Patient is receiving a renal transplant only * The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis. * Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion * Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF * No evidence of donor-specific antibody presently or historically * Panel Reactive Antibody (PRA) less than or equal to 20 Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four-hour drive, for the first month of the protocol so that they can be monitored closely in the early post-transplant period. Exclusion Criteria: * Clinically active bacterial, fungal, viral or parasitic infection * Pregnancy * Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant or FCRx infusion * Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI) * Positive crossmatch between donor and recipient * Evidence for immunologic memory against donor * Body Mass Index (BMI) \>35 or \<18 * Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), human immunodeficiency virus (HIV)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-10-11