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Kidney TransplantationPhase 1TEACHNCT03504241

Tolerance by Engaging Antigen During Cellular Homeostasis

A Phase 1 study testing Donor-derived Mesenchymal Stromal Cells, alemtuzumab and belatacept in people with Kidney Transplantation and Renal Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Donor-derived Mesenchymal Stromal Cells, alemtuzumab and belatacept
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
30 Jul 2018to 16 Sep 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Recipient:
  • Adult candidates of an human leukocyte antigen (HLA)-non-identical, living-donor kidney transplant:
  • --Candidates must meet the United Network for Organ Sharing (UNOS) criteria, including laboratory criteria, for transplant listing;
  • Evidence of established immunity to Epstein-Barr Virus (EBV) as demonstrated by serologic testing;
  • Serological evidence of prior Cytomegalovirus (CMV) infection if donor is CMV positive;
  • For women of child bearing potential:
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  • A negative serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of start of study medication; and
  • Agreement to use contraception:
  • --- According to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective
  • ----Female recipients of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for 18 months after the first dose of study therapy.
  • Donor:
  • Meets institutional selection criteria for organ and bone marrow donation:
  • --All donors will be screened and tested in accordance with:
  • (i) FDA 21 CRF 1271.85 requirements for donors of human cells, tissues, and cellular- and tissue-based products (HCT/P); and
  • (ii) standards for living kidney donors testing for infection established by the United Network for Organ Sharing (UNOS).
  • Ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvest.

Who cannot join

  • Recipient:
  • History of any immunodeficiency syndrome (including Human Immunodeficiency Virus-1 (HIV-1) and HIV-2);
  • Positive anti-Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR), anti-Hepatitis C Virus (HBV) PCR, or HBV surface antigen;
  • History of malignancy within 5 years of enrollment or any history of hematogenous malignancy or lymphoma; --Exception: Participants with curatively treated non-melanomatous skin cancer or curatively treated cervical carcinoma in situ may be enrolled.
  • Underlying renal disease with high likelihood of recurrence, including but not limited to:
  • primary focal segmental glomerulosclerosis (FSGS),
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  • Type I or II membranoproliferative glomerulonephritis (MPGN),
  • hemolytic-uremic syndrome and
  • thrombotic thrombocytopenic purpura (HUS/TTP) syndrome. ---Subject(s) with end-stage renal disease (ESRD) of unknown etiology and/or has no histologically confirmed diagnosis, may be enrolled into the study as long as there are no clinical signs or symptoms consistent with excluded clinical diagnoses.
  • History of active M. tuberculosis:
  • --Participants with a history of latent M. tuberculosis (LTB) as defined by positive testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON®-Gold TB or T-SPOT-TB assay must:
  • have completed treatment for LTB and
  • have a negative chest x-ray. ----All participants will undergo IGRA testing for M tuberculosis within 3 months prior to transplant.
  • Current or historical evidence of donor-specific antibody;
  • Immunosuppressive drug therapy within one year prior to enrollment.
  • May not be taking or have taken prednisone, cyclosporine A, tacrolimus, azathioprine, Mycophenolate Mofetil (MMF), cyclophosphamide, methotrexate, infliximab, etanercept, or other agents which have a primary therapeutic effect of immunosuppression in the year prior to transplantation.
  • May not have taken depletional anti-lymphocyte agents at any time.
  • ---Exceptions:
  • Short (≤ 30 days) courses of topical or inhaled steroids are permitted, as are
  • Short oral or parental pulses for a documented hypersensitivity reaction.
  • Active autoimmune disease requiring ongoing immunosuppressive therapy or other conditions in which there is an anticipated need for immunosuppressive maintenance therapy;
  • Uncompensated congestive heart failure, pulmonary edema, or symptomatic pulmonary hypertension;
  • Active severe infection within a month of the screening visit;
  • Use of an investigational drug within 30 days of the screening visit;
  • Presence of any medical condition that the investigator deems incompatible with trial participation; or
  • Inability or unwillingness to comply with protocol monitoring and therapy.
  • Donor:
  • History of blood donation to the recipient;
  • Evidence of prior Cytomegalovirus (CMV) infection if the recipient is CMV negative;
  • History of HIV-1/HIV-2 infection;
  • Positive HCV PCR, HBV PCR or HBV surface antigen;or
  • Presence of any medical condition that the investigator deems incompatible with trial participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Health System

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)

Anti-rejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent rejection of the new organ. Long-term use of these medicines places transplant recipients at higher risk of serious infections and certain types of cancer.

The purpose of this study is to determine if:

  • it is safe to give mesenchymal stromal cells (MSCs) to kidney transplant recipients, and
  • the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop all anti-rejection drugs, without rejection of their kidney (renal) allograft, a process called "immunosuppression withdrawal".
Read the detailed description

Background:The most common problem following a kidney transplant is the development of acute or chronic rejection. Rejection is the immunologic reaction in which the body refuses to accept the transplanted organ. The body's immune system will make destructive antibodies that will attempt to attack the transplanted organ.

In order to prevent organ rejection, all patients receiving an allograft (a graft transplanted between genetically non-identical individuals of the same species) must take anti-rejection (immunosuppressive) therapy. These medications function by lowering the body's natural immune system. Often these medications are associated with significant side effects ranging from infections to cancer.

Study:

This is a single center, open label, dose-escalation clinical trial in 6 adult recipients of Human Leukocyte Antigen (HLA)- non-identical, living-donor renal allografts. All participants will receive induction therapy with alemtuzumab followed by maintenance therapy with sirolimus and belatacept.

A total of 2 dosing cohorts of 2 recipients each will receive 12 infusions of donor-derived MSCs starting on Day 42 post-transplant and every 4 weeks starting on Day 56 post-transplant, with a minimum of 7 days between the first and second MSC infusions.

The primary objective is to determine whether immune reconstitution after lymphocyte depletion in the setting of co-stimulatory blockade and systemic MSC-derived donor antigen can promote operational tolerance in recipients of kidney allografts.

Participants will be evaluated for eligibility for sirolimus withdrawal any time between week 52 and week 104 post-transplant. Participants who successfully complete sirolimus withdrawal will remain on belatacept monotherapy for at least 24 weeks before being assessed for eligibility to discontinue belatacept. Participants who successfully complete Immunosuppression Withdrawal (ISW) will then undergo 24 weeks of high frequency follow up followed by 132 weeks of standard follow up.

Study participation may continue for up to seven (7) years after kidney transplant surgery.

  • IMPORTANT NOTICE: * The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
Being tested
Donor-derived Mesenchymal Stromal Cells, alemtuzumab, belatacept, sirolimus, mycophenolate mofetil
Keywords
mesenchymal stromal cells (MSCs), anti-rejection drugs, operational tolerance

What participants receive

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

  • Donor-derived Mesenchymal Stromal CellsBiological

    Also called Donor-derived MSCs, human bone marrow derived MSCs, hBM-MSC, EPIC-MSC-ITN2015-IVF-0X

    These MSCs are a cellular product derived from bone marrow and propagated ex vivo using FDA-approved, clinically applicable methods. Their use in kidney transplantation has been associated with a good safety profile.

  • alemtuzumabDrug

    Also called Campath®, Lemtrada®

    Alemtuzumab, 30 mg, given once intravenously (IV) over three hours. The infusion of alemtuzumab shall begin within 24 hours of transplantation surgery and shall be given prior to the first dose of belatacept.

  • belataceptDrug

    Also called Nulojix®, LEA29Y

    Belatacept will be given as an intravenous (IV) infusion of 10mg /kg over 1 hour on transplantation postoperative Day 0, Days 5 and 14, then every 2 weeks (± 2 days) for 5 additional doses.Thereafter, belatacept will be given once every 4 weeks (± 5 days) at 10 mg/kg through 24 weeks post-transplant, then at 5 mg/kg every 4-weeks until the participant is evaluated for belatacept discontinuation.

  • sirolimusDrug

    Also called Rapamune®

    Rapamune® (sirolimus) (Wyeth Pharmaceuticals Inc., Philadelphia, PA) will be started on transplantation postoperative day 1 at a dose of 2 mg/day orally and adjusted to maintain goal 24-hour trough levels of 8-10 ng/ml. Participants who experience grade 3 sirolimus toxicity will undergo dose reduction.

  • mycophenolate mofetilDrug

    Also called CellCept®

    Per protocol, and, only permitted in cases of sirolimus intolerance.

  • mycophenolate acidDrug

    Also called Myfortic®

    Per protocol, and, only permitted in cases of sirolimus intolerance.

  • prednisoneDrug

    Also called corticosteroid

    Per protocol, and, only permitted in cases of sirolimus intolerance.

Study groups in NCT03504241
Study groupRoleWhat they receive
MSCs 10^4 cells/kg+anti-rejection drugsExperimentalThe first dosing cohort of 2 participants will receive 12 infusions of 10^4 donor-derived Mesenchymal Stromal Cells (MSCs) cells/kg every 4-weeks.
Receives: Biological: Donor-derived Mesenchymal Stromal Cells; Drug: alemtuzumab; Drug: belatacept; Drug: sirolimus; Drug: mycophenolate mofetil; Drug: mycophenolate acid; Drug: prednisone
MSCs 10^5 cells/kg+anti-rejection drugsExperimentalIf the first 3 infusions of 10^4 donor-derived Mesenchymal Stromal Cells (MSCs) cells/kg are well tolerated, this cohort of 2 participants will receive 12 infusions of 10^5 cells/kg every 4-weeks.
Receives: Biological: Donor-derived Mesenchymal Stromal Cells; Drug: alemtuzumab; Drug: belatacept; Drug: sirolimus; Drug: mycophenolate mofetil; Drug: mycophenolate acid; Drug: prednisone

What is being measured

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

  1. Proportion of Participants who Achieve Operational Tolerance

    Operational tolerance (to their kidney transplant) defined by participant remaining off all immunosuppression for 52 weeks after completion of Immunosuppression Withdrawal (ISW) with:

    • No evidence of biopsy-proven allograft rejection after initiation of ISW;
    • Acceptable renal function, defined as an estimated GFR > 60 ml/min/1.73cm^2 calculated using the CKD-EPI equation or a serum creatinine that has increased no more than 25% above baseline, as assessed at the week 52 visit after completion of ISW;
    • No evidence of sustained transplant renal derived pathologic proteinuria, defined as a persistent protein creatinine ratio of greater than 0.5; and
    • No Donor Specific Antibodies (DSA) at any time after completion of ISW.

    Measured: 52 weeks after completion of Immunosuppression Withdrawal (ISW)

Secondary outcomes (11)

  1. Proportion of Participants who Remain Off Immunosuppression

    For the duration of their study participation, after completion of immunosuppression withdrawal (ISW).

    Measured: From ISW completion to end of study participation (up to approximately 5 years)

  2. Proportion of Participants who Return to Immunosuppression

    Resumption of immunosuppressive therapy post completion of Immunosuppression Withdrawal (ISW), per standard of care.

    Measured: From ISW completion to end of study participation (up to approximately 5 years)

  3. Proportion of Participants who Achieve Belatacept Monotherapy

    Belatacept monotherapy, defined as remaining on belatacept as the sole maintenance regimen for 48 weeks with:

    • No evidence of biopsy-proven allograft rejection, while on belatacept monotherapy;
    • Acceptable renal function, defined as an estimated GFR > 60 ml/min/1.73m^2 calculated using the CKD-EPI equation or a serum creatinine that has increased no more than 25% above baseline, as assessed at week 48 on belatacept monotherapy;
    • No evidence of sustained transplant renal derived pathologic proteinuria, defined as a persistent protein creatinine ratio of greater than 0.5, while on belatacept monotherapy; and
    • No Donor Specific Antibodies (DSA) at any time while on belatacept monotherapy.

    Measured: 48 weeks from the time of last sirolimus dose

  4. Proportion of Participants who Die

    This analysis will include all participants who provide informed consent for study participation and receive any form of study therapy including alemtuzumab, sirolimus, belatacept, or MSC infusions.

    Measured: From kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)

  5. Time from Transplant to the First Episode of Rejection

    Kaplan-Meier Analysis of time-to-occurrence to the first episode of kidney allograft rejection.

    Measured: From kidney transplantation to completion of study (up to approximately 7 years)

  6. Incidence of Participants who Develop Donor Specific Antibody (DSA)

    Participants that Develop de novo Anti-Human Leukocyte Antigen (HLA) Antibody or Donor Specific Antibodies (DSA).

    Measured: From study enrollment to completion of study (up to approximately 7 years)

  7. Incidence of Adverse Events Attributable to Mesenchymal Stromal Cells (MSC) Administration

    According to medical assessment/outcomes, investigator's brochure for MSCs, literature et al.

    Measured: From initial MCS infusion (day 42 post kidney transplant) to end of study participation (up to 7 years)

  8. Frequency of Select Adverse Events (AEs)

    Select AEs include:

    • Infection
    • Malignancy
    • Wound complications, defined as wound dehiscence, hernia or lymphocele

    Measured: From kidney transplantation to completion of study (up to approximately 7 years)

  9. Incidence of Post-Transplant Diabetes

    New onset diabetes status post transplant (posttransplantation diabetes mellitus [PTDM])

    Measured: From post kidney transplantation to completion of study (up to approximately 7 years)

  10. Frequency of Antibody-Mediated Acute Cellular Rejection

    Using the 2017 Banff Classification of Renal Allograft Pathology.

    Measured: From kidney transplant to completion of study (up to approximately 7 years)

  11. Frequency of Antibody-Mediated Chronic Rejection

    Using the 2017 Banff Classification of Renal Allograft Pathology.

    As measured by the incidence of biopsy-proven chronic allograft nephropathy/IF/TA

    Measured: From kidney transplant to completion of study (up to approximately 7 years)

Timeline

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

  1. First posted20 Apr 2018
  2. Study start30 Jul 2018
  3. Primary completion6 Sep 2023
  4. Study completion16 Sep 2025

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03504241
Sponsor's protocol ID
DAIT ITN062ST
Other IDs
UM1AI109565, NIAID CRMS ID#: 20676
Acronym
TEACH
Status last verified
Feb 2026
First submitted
12 Apr 2018
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share data upon completion of the study in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Donor-derived Mesenchymal Stromal Cells, alemtuzumab and belatacept in people with Kidney Transplantation and Renal Transplantation, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 16 inclusion and 32 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: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants who Achieve Operational Tolerance (time frame: 52 weeks after completion of Immunosuppression Withdrawal (ISW)). 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 NCT03504241.

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 13 Feb 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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