Clinical trial NCT03726307: Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study
Official title: Allogeneic Regulatory Dendritic Cell (DCreg) Therapy in Live-Donor Renal Transplant Recipients
Conditions: Kidney Transplant
Renal Transplant Recipients
Summary: This study will evaluate the safety and feasibility of treatment involving a single infusion of donor-derived regulatory dendritic cells (DCreg) in first time, living donor renal transplant recipients.
DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) living kidney donors and infused into the respective recipients 7 days before renal transplantation. This study will enroll 28 subjects (14 recipients, 14 donors). The duration of follow-up will be:
* 1 week following the leukapheresis procedure for donors and
* 2 years following their DCreg infusion for kidney recipients.
Interventions:
description: DCreg 0.5 (±0.1) million cells/kilogram body weight infused as a single dose.<br/>Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:<br/>* mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and<br/>* the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).<br/>Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
name: DCreg: 0.5 million cells/kg+SOC
other_name: Regulatory Donor-Derived Dendritic Cells (DCreg)
type: Biological
description: DCreg 1.2 (±02) million cells/kilogram body weight infused as a single dose.<br/>Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:<br/>* mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and<br/>* the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).<br/>Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
name: DCreg: 1.2 million cells/kg+SOC
other_name: Regulatory Donor-Derived Dendritic Cells (DCreg)
type: Biological
description: DCreg 2.5 to 5.0 million cells/kilogram body weight infused as a single dose.<br/>Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:<br/>* mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and<br/>* the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).<br/>Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
name: DCreg:2.5 to 5.0 million cells/kg+SOC
other_name: Regulatory Donor-Derived Dendritic Cells (DCreg)
type: Biological
Study arms:
design_group_description: N=3 participants will receive 0.5 (± 0.1) million cells/kg body weight as a single infusion.<br/>Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:<br/>* mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and<br/>* the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).<br/>Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
design_group_title: DCreg: 0.5 million cells/kg+SOC
design_group_type: Experimental
design_group_description: N=3 participants will receive 1.2 (± 0.2) million cells/kg body weight as a single infusion.<br/>Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:<br/>* mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and<br/>* the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).<br/>Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
design_group_title: DCreg: 1.2 million cells/kg+SOC
design_group_type: Experimental
design_group_description: N=8 participants will receive 25 to 5.0 million cells /kg body weight as a single infusion.<br/>Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:<br/>* mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and<br/>* the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).<br/>Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
design_group_title: DCreg:2.5 to 5.0 million cells/kg+SOC
design_group_type: Experimental
Sponsor: University of Pittsburgh
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: Allogeneic Regulatory Dendritic Cell(National Institute of Allergy and Infectious Diseases)
lang: EN