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

NCT07083830 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: STU00222957
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events Following Escalating Doses of ECP-DL Cells

  To determine the safety profile of escalating doses of ECP-DL cells administered to patients undergoing living donor kidney transplantation.

  From Day -7 (first ECP-DL infusion) through 24 months post transplant

Secondary Outcomes (5)

• Incidence of Transplant-Related Adverse Events

  Baseline through 24 months post-transplant.

• Incidence and Severity of Infections

  Baseline through 24 months post-transplant

• Changes in Peripheral Blood Lymphocyte Subpopulations

  Baseline, Day 0, Day 7, Day 30, and Month 6

• Change in Donor-Specific T Cell Response as Measured by Mixed Lymphocyte Reaction (MLR) and ELISPOT Assays

  Baseline, Day 30, and Month 6

• Quantitative Changes in Plasma and Urine Proteins Identified by Mass Spectrometry-Based Proteomic Analysis

  Baseline, Day 30, and Month 6

Study Arms (1)

ECP-DL Cell Therapy Arm

EXPERIMENTAL

Participants will receive escalating doses of ECP-DL (extracorporeal photopheresis-derived dendritic-like) cells starting on Day -7 prior to living donor kidney transplantation. The intervention aims to evaluate the safety and immunomodulatory effects of ECP-DL cell infusion in the context of renal transplantation.

Device: ECP-DL treated mononuclear cell infusion

Interventions

ECP-DL treated mononuclear cell infusion DEVICE

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.

ECP-DL Cell Therapy Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient age ≥30 and less than 70 years old.
• Donor age ≥18 and ≤ 70 years old.
• Recipient of a first kidney transplant from a living unrelated or living related donor that is not HLA-identical to the donor.
• Donor willing to undergo cell collection for ECP-DL cell preparation and infusion.
• Donors will be screened and tested for HIV-1 (antigen and nucleic acid), HIV-2, hepatitis B virus (HBV, nucleic acid and surface and core antigen), hepatitis C virus (HCV, antigen and nucleic acid), Treponema pallidum (syphilis), West Nile Virus (WNV), and CJD (screening only). and tested for human T-lymphotropic virus types 1 and 2 (HTLV-1, HTLV-2) and CMV, in accordance with established UNOS guidelines for solid organ donors.
• Donors and recipients who test negative for TB using QuantiFERON gold assay.
• Must be willing and able to comply with protocol-required visit schedule and visit requirement.
• Patients who are single-organ recipients (kidney only).
• Women who are of childbearing potential must have a negative serum pregnancy test before transplantation and agree to use a medically acceptable method of contraception throughout the treatment period. Both male and female transplant recipients must agree to the use of highly effective birth control for 12 months following ECP-DL procedure. Individuals unwilling to do so will be excluded from study participation.
• Subjects are able to understand the consent form and give written informed consent.

You may not qualify if:

• RECIPIENT
• Known sensitivity or contraindication to everolimus, tacrolimus, or psoralen.
• Aphakia.
• Has undergone splenectomy
• Patients with light-sensitive diseases including (but not limited to) systemic lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porhyria, xeroderma pigmentosum, and albinism
• Patient with significant or active infection.
• Patients with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
• Patients with PRA \>80%
• Patients with current or historic donor specific antibodies
• Body Mass Index (BMI) of \< 18 or \> 40
• Patients who are pregnant or nursing mothers
• Patients whose life expectancy is severely limited by diseases other than renal disease
• Ongoing active substance abuse, drug or alcohol
• Major ongoing psychiatric illness or recent history of noncompliance
• Significant cardiovascular disease

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Joseph Leventhal, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Jennifer Schneiderman, MD, MS

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Cuasay (RN)

CONTACT

312-926-1076; erica.cuasay@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 24, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 25, 2027
• Study Completion (Estimated): August 25, 2028
• Last Updated: February 10, 2026

Record last verified: 2026-02