NCT07083830

ECP-DL Cell Infusion for Induction in Living Donor Kidney (LDK) Transplants

A Phase I, Single Center Trial of Donor Extracorporeal Photopheresis (ECP) Treated Cell Infusion (ECP-DL) Plus Post-transplant ECP for the Prevention of Rejection in Living Donor Kidney Transplant Recipients

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 trial, 36 month duration for subjects with end-stage renal disease (ESRD). The objectives of the trail are1) Determine the safety of ECP-DL cell infusion in living donor renal transplant recipients. 2) Determine rates of graft rejection and compare to historical controls. One week prior to planned LDK transplant the donor and recipient pair will be seen for ECP-DL preparation and infusion. Donors will undergo one single unstimulated peripheral blood mononuclear cell collection using the THERAKOS® CELLEX® Photopheresis System; the cell product will then undergo ECP treatment to make ECP-DL, which will then be infused into the recipient. One week later, recipients (n=12) will undergo LDK transplant using standard of care maintenance immunosuppression without antibody induction therapy. Subsequent patients will receive cell infusions in escalating cell doses. A minimum of two months will be used as an interval between ECP-DL treatment in each tier. A staggered approach for moving to the next tier will be employed waiting no less than two months to ensure absence of adverse events using the following tier dosing schema: Tier 1: 0.5 x 10\^9 ECP-DL treated cells (n=4) Tier 2: 1 x 10\^9 ECP-DL treated cells (n=4) Tier 3: 2 x 10\^9 ECP-DL treated cells (n=4) Following transplant, LDK recipients will undergo ECP using the Therakos system on two consecutive days per month for 6 months (12 treatments). Peripheral IV access will be used whenever possible.

Conditions

• Kidney Transplant Failure and Rejection
• Kidney Transplant; Complications

Interventions

Type	Name	Description
DEVICE	ECP-DL treated mononuclear cell infusion	Participants in this study will undergo the infusion of donor white blood cells treated with ECP one week before their living donor kidney transplant, combined with standard of care antirejection medications. You will also then have ECP treatments using your own blood on two consecutive days once per month for 6 months. This combination is intended to cause your immune system to create a state called tolerance to the donor kidney. The ECP procedure has not been approved to prevent rejection after kidney transplant and the use of ECP to prevent rejection of transplanted organs is experimental, and is not a part of standard treatment which is based on the long term use of anti-rejection drugs such as tacrolimus (Prograf), everolimus, and prednisone.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-12-25
• Completion: 2028-08-25
• First posted: 2025-07-24
• Last updated: 2026-02-10

Regulatory

• FDA-regulated device study