An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
The purpose of this study is to assess the safety, tolerability, preliminary efficacy, and overall benefit of FCR001 cell therapy in previously transplanted recipients of a kidney from a living donor. FCR001 is a novel, cryopreserved allogeneic somatic cell therapy, derived from mobilized peripheral blood mononuclear cells from the same donor as the allograft, and containing hematopoietic progenitor cells, facilitating cells, and αβ T cells. The rationale is to establish durable chimerism and donor-specific tolerance in the recipient enabling freedom from chronic immunosuppression (IS) and its associated toxicities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enriched hematopoietic stem cell infusion
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Proportion of FCR recipients (FCR-R) who are free from immunosuppression (IS), without biopsy-proven acute rejection (BPAR), at 24 months post-FCR001 infusion
Time frame: From infusion to 24 months
Change in renal function (estimated Glomerular Filtration Rate [eGFR] by Modification of Diet in Renal Disease [MDRD4]) from baseline (Day 1, prior to FCR001 infusion) to Month 24 in FCR recipients
Time frame: From Day 1 prior to infusion to 24 months
Renal allograft function (eGFR by MDRD4)
Time frame: From infusion to 24 months and 60 months
Change in renal allograft function over time by MDRD4
Time frame: From infusion to 24 months and 60 months
Renal allograft function (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
Time frame: From infusion to 24 months and 60 months
Change in renal allograft function over time by CKD-EPI
Time frame: From infusion to 24 months and 60 months
Time to event for the composite of BPAR, renal graft loss, death, or lost to follow-up and each component
Time frame: From infusion to 60 months
Incidence of composite endpoint of BPAR, renal graft loss, or death
Time frame: From infusion to 12 months, 24 months and 60 months
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and AEs leading to study and/or regimen discontinuation
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Time frame: From informed consent to 12 months, 24 months and 60 months
Incidence of BK viremia, viruria, infection, and nephropathy
Time frame: From informed consent to 12 months, 24 months and 60 months
Incidence of donor chimerism by visit
Time frame: From infusion to 60 months
Incidence of acute and chronic GvHD
Time frame: From infusion to 60 months
Incidence of engraftment syndrome
Time frame: From infusion to 60 months
Incidence of recipient autologous apheresis product infusion
Time frame: From infusion to 60 months
Renal graft survival for recipients transiently chimeric
Time frame: From infusion to 60 months
Incidence of composite endpoint of BPAR, death, renal graft loss, or lost to follow-up in FCR-R who did not achieve durable chimerism or able to wean or remain off IS
Time frame: From infusion to 60 months