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AzTrials

Living Donor Kidney TransplantationPhase 1NCT03943238

TLI, TBI, ATG & Hematopoietic Stem Cell Transplantation and Recipient T Regs Therapy in Living Donor Kidney Transplantation

A Phase 1 study testing Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs in people with Living Donor Kidney Transplantation, run by Stanford University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Living Donor Kidney Transplantation
What is being tested?
Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
2 sitesUnited States
Study dates
1 Feb 2020to 1 Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All consenting adults who are 18 to 65 years, living donor renal transplant recipients at Stanford University Medical Center or Northwestern Medicine who have a haplotype matched (minimum single Human Leukocyte Antigen - DR locus (HLA-DR) and HLA-A or B match) living related or unrelated donor.
  • Patients who agree to participate in the study and sign an Informed Consent.
  • Patients who have no known contraindication to administration of rabbit ATG or radiation.
  • Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year posttransplant

Who cannot join

  • Previous treatment with rabbit ATG or a known allergy to rabbit proteins.
  • History of malignancy with the exception of non-melanoma skin malignancies.
  • Pregnant women or nursing mothers.
  • Serological evidence of HIV, Hepatitis B surface antigen positive (HBsAg+), or Hepatitis C infection. Epstein Barr Virus (EBV) positive to EBV negative.
  • Leukopenia (with a white blood cell count < 3000/mm3) or thrombocytopenia (with a platelet count < 100,000/mm3).
  • Panel Reactive Antibody (PRA) greater than 80% or demonstration of historic and/or current donor specific antibody (DSA)
Show all 9Show fewer
  • Prior organ transplantation
  • High risk of primary kidney disease recurrence
  • Advanced coronary or vascular disease.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kevin Ly, BS contact

650-497-6057

kevinly@stanford.edu

Stephan Busque, MD contact

650-498-6189

sbusque@stanford.edu

United States2 sites, 2 recruiting

  • Nothwestern University

    Chicago, Illinois, 60611

    Leah Goudy, RN, 312-694-0242, leah.goudy@northwestern.edu

    Joseph Leventhal, MD, 312-695-8900, jleventh@nm.org

    Recruiting

  • Stanford University

    Palo Alto, California, 94305

    Renata Gilfanova, 650-736-0245, Rgilfan@stanford.edu

    Stephan Busque, MD, 650-498-6189, sbusque@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Study of Total Lymphoid Irradiation, Total Body Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+, T-cell and Recipient T Regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation

This study will determine whether a preparatory regimen including total lymphoid irradiation (TLI), total body irradiation (TBI), anti-thymocyte globulin (ATG) and infusion of the donor hematopoietic stem cells when given along with recipient regulatory T cells (Tregs) will allow for eventual discontinuation of anti-rejection drugs after living donor kidney transplantation.

Read the detailed description

It has been demonstrated that hematopoietic mixed chimerism or the coexistence of both donor and recipient immune cells can lead to tolerance to the graft in absence of graft versus host disease (GVHD). The goal of this pilot study is to determine if recipients of living donor kidney transplant can be successfully withdraw from immunosuppressive drugs. The patients will receive a preparatory regimen consisting of TLI and a low single dose of TBI and ATG following their kidney transplantation. Two weeks later, they will receive purified hematopoietic stem cells (CD34+) and Tcells that have been collected 6 weeks prior from their kidney donor. Regulatory T cells (Tregs) that have been collected from the recipient prior to the transplantation and expanded in vitro will be infuse the following day to enhance the chance of engraftment of the donor bone marrow cells. If chimerism develops and persists, the immunosuppressive drug will be tapered and stop. Mycophenolate mofetil (MMF) will be stopped 12 months after transplantation and if the chimerism remains stable, tacrolimus will be stopped 6 months later. The dose of Tregs will be escalated if the % of donor chimerism is not at least 25% during the first 60 days.

Being tested
Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs
Keywords
kidney transplant, Immunological Tolerance, Tregs, Stem cells

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion of Donor Hematopoetic Stem Cells and Recipient TregsBiological

    Living donor kidney transplant recipients will receive after a preparatory regimen of total lymphoid irradiation, total body irradiation and anti-thymocyte globulin an infusion of purified donor CD34+ of >10 x10^6 cells /Kg, 100 x 10^6 donor T cell/ Kg and and an escalated dose of recipient Tregs starting at 25 x10^6/Kg.

Study groups in NCT03943238
Study groupRoleWhat they receive
Combined kidney/stem cell transplants and recipient's TregsExperimentalPreparatory regimen including TLI, TBI, ATG after kidney transplantation followed by infusion of donor CD34+, T cell and recipient Tregs
Receives: Biological: Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Count of participants with sustained mixed chimerism of >25% at 18 months

    Chimerism is defined as the co-existence of the immune cell from both the donor and the recipient.

    Measured: Month 18

  2. Count of participants able to withdraw from immunosuppressive drugs without evidence of rejection at 18 months

    Measured: Month 18

Secondary outcomes (2)

  1. Count of participants with adverse events associated with the infusion of the Tregs cell product

    Measured: up to 2 years

  2. Count of participants with bacterial, viral, or fungal infections

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2019
  2. Study start1 Feb 2020
  3. Primary completion1 Nov 2029 (estimated)
  4. Study completion1 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
In this phase 1 study, a conditioning regimen of Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donr CD34+, T cell and Recipient T regulatory Cell Transfusion in Human Leukocyte Antigen Mismatched Living Donor Kidney Transplantation will be studied
Masking
None (open label)
Enrolment
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03943238
Sponsor's protocol ID
50540
Status last verified
Jun 2026
First submitted
7 May 2019
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leventhal JR, Ildstad ST. Tolerance induction in HLA disparate living donor kidney transplantation by facilitating cell-enriched donor stem cell Infusion: The importance of durable chimerism. Hum Immunol. 2018 May;79(5):272-276. doi: 10.1016/j.humimm.2018.01.007. Epub 2018 Mar 2.

    PubMed 29409743

  • Ildstad ST, Leventhal J, Wen Y, Yolcu E. Facilitating cells: Translation of hematopoietic chimerism to achieve clinical tolerance. Chimerism. 2015 Apr 3;6(1-2):33-9. doi: 10.1080/19381956.2015.1130780. Epub 2016 Jan 8.

    PubMed 26745761

  • Scandling JD, Busque S, Shizuru JA, Lowsky R, Hoppe R, Dejbakhsh-Jones S, Jensen K, Shori A, Strober JA, Lavori P, Turnbull BB, Engleman EG, Strober S. Chimerism, graft survival, and withdrawal of immunosuppressive drugs in HLA matched and mismatched patients after living donor kidney and hematopoietic cell transplantation. Am J Transplant. 2015 Mar;15(3):695-704. doi: 10.1111/ajt.13091.

    PubMed 25693475

  • Scandling JD, Busque S, Shizuru JA, Engleman EG, Strober S. Induced immune tolerance for kidney transplantation. N Engl J Med. 2011 Oct 6;365(14):1359-60. doi: 10.1056/NEJMc1107841. No abstract available.

    PubMed 21991976

  • Scandling JD, Busque S, Lowsky R, Shizuru J, Shori A, Engleman E, Jensen K, Strober S. Macrochimerism and clinical transplant tolerance. Hum Immunol. 2018 May;79(5):266-271. doi: 10.1016/j.humimm.2018.01.002. Epub 2018 Jan 9.

    PubMed 29330112

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs in people with Living Donor Kidney Transplantation, run by Stanford University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin Ly, BS (650-497-6057, kevinly@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of participants with sustained mixed chimerism of >25% at 18 months (time frame: Month 18). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03943238, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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