Light therapy and donor cells aim to stop kidney rejection
NCT ID NCT07083830
First seen Jun 27, 2026 · Last updated Aug 11, 2026 · Updated 2 times
Summary
This early-stage trial tests whether giving kidney transplant recipients a special treatment made from their donor's cells, combined with a light-based therapy called photopheresis, can safely reduce the risk of organ rejection. About 24 adults receiving their first kidney transplant will take part. The main goal is to check safety and see if this approach lowers rejection rates compared to past patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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