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

Launched by NORTHWESTERN UNIVERSITY · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment to help people who need a kidney transplant from a living donor. The treatment involves collecting special cells from the donor’s blood, treating these cells with a process called extracorporeal photopheresis (ECP), and then giving these treated cells to the transplant recipient before their surgery. The main goal is to see if this cell treatment is safe and if it can help reduce the chance that the recipient’s body will reject the new kidney. After the transplant, recipients will also receive additional ECP treatments once a month for six months to support their immune system.

People who might be eligible for this study are adults between 30 and 70 years old who are receiving their first kidney transplant from a living donor who is not a perfect tissue match. Both donors and recipients need to be healthy enough to participate, pass certain infection tests, and agree to follow the study schedule. Participants should not have certain health problems like active infections, serious heart issues, or recent cancers, and women of childbearing age must agree to use birth control during the study. If chosen, donors will have blood collected before the transplant, and recipients will receive the treated cells about a week before their surgery, followed by regular treatments afterward. This study is still in the early phase, focusing mainly on safety, and will include a small number of participants to carefully monitor any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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
• • Malignancy within 3 years, excluding nonmelanoma skin cancers
• • Subjects with cerebrovascular vascular disease with recent (\< 6 months) stroke
• • Serologic evidence of infection with HIV or HBVs Ag positive
• • Recipient is EBV serologic negative
• • Donor CMV serologic positive to recipient CMV serologic negative
• • Recipient tests positive for HCV viral load by PCR
• • Patients with a screening/baseline total white blood cell count \< 4,000/mm3; platelet count \< 100,000/mm3; triglyceride \> 400 mg/dl; total cholesterol \> 300 mg/dl
• • Investigational drug within 30 days prior to transplant surgery
• • Anti-T cell therapy within 30 days prior to transplant surgery
• • Documented severe liver disease, defined as bridging fibrosis or cirrhosis on liver biopsy
• • Poorly controlled diabetes, defined as HbA1c of \> 8.0
• • PT/INR \> 2.0
• • SBP \< 90 or \> 180mm Hg, HR \> 120 or \<50bpm, Temp \> 99.5F on day of proposed ECP-DL procedure
• • Patients receiving concomitant enteral or topical medical therapy with potentially photosensitizing effects
• • DONOR
• • Lack of possible peripheral IV access (two access sites)
• • Has undergone splenectomy
• • Donor tests positive for HCV viral load by PCR
• • PT/INR \> 2.0; or known hyper or hypo coagulable disorders
• • Hgb \< 10.0
• • platelet count \< 100,000
• • SBP \< 90 or \> 160mm Hg, HR \> 120 or \<50bpm, Temp \> 99.5F on day of proposed ECP-DL procedure
• • Donors who cannot tolerate extracorporeal volume during PBMC collection