Could 'Peacekeeper' cells free liver transplant patients from lifelong drugs?
NCT ID NCT03577431
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This early-phase trial tests whether infusing specially grown donor-specific regulatory T cells (Tregs) can allow liver transplant recipients to safely reduce or stop their anti-rejection medications. Nine participants will receive a single dose of these cells and be monitored for side effects and whether they can maintain a healthy liver without standard immunosuppression. The goal is to see if this cellular therapy can induce 'operational tolerance'—a state where the body accepts the donor organ without needing lifelong drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- donor-specific regulatory T cells (arTreg-CSB)
- What this could lead to
- If successful, this could allow some liver transplant recipients to stop or reduce lifelong anti-rejection medication without rejecting the organ.
- What could go wrong
- This is a very early, tiny trial (9 people) focused on safety, not proof of effectiveness. The approach may not work or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
9 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Feb 2026
- Lead sponsor
-
A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
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Anyone
- Healthy volunteers
-
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: Eligibility: Recipient: * Individuals must meet all of the following criteria to be eligible for this study: 1. Able to understand and provide informed consent 2. End-stage liver disease and listed for a living or deceased-donor primary solitary liver transplant 3. Agreement to use contraception 4. Positive Epstein-Barr virus (EBV) antibody test and 5. In the absence of contraindication, vaccinations must be up to date per the DAIT Guidance for Patients in Transplant Trials (Refer to the Manual of Procedures) Living Donor: * Living donors must meet all of the following criteria to be eligible for this study: 1. Able to understand and provide informed consent 2. Meets site-specific clinical donor eligibility requirements 3. Meets donor eligibility manufacturing requirements within 7 days prior to blood collection for manufacturing and 4. Willingness to donate appropriate biologic samples. Deceased Donor: Deceased donors must meet the following criteria for their recipients to be eligible for this study: 1\. Meets site-specific clinical donor eligibility requirements and 2. Meets donor eligibility manufacturing requirements. Note: * There are several stages to this study. * Eligibility is evaluated at many time points during the study to assess whether a participant is safe to proceed to the next study stage. Exclusion Criteria: Recipient: * Individuals who meet any of the following criteria will not be eligible for this study: 1. History of previous organ, tissue or cell transplant requiring or potentially requiring immunosuppression 2. For cytomegalovirus (CMV) antibody negative recipients, a (CMV) antibody positive donor 3. Known contraindication to cyclophosphamide or Mesna administration 4. Serologic evidence of human immunodeficiency virus (HIV)-1/2 infection 5. The need for chronic anti-coagulation that cannot be safely discontinued for a minimum of 1 week to safely perform a liver biopsy 6. End stage liver disease secondary to autoimmune etiology (autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis) or other contraindications to drug withdrawal 7. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule 8. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may interfere with study compliance 9. Past or current medical problems, treatments or findings that are not listed above, which, in the opinion of the investigator, may: \-- pose additional risks from participation in the study, * interfere with the candidate's ability to comply with study requirements, or * impact the quality or interpretation of the data obtained from the study. 10. History of malignancy with a risk of recurrence judged by the investigator to be \>1%, except for: \-- hepatocellular carcinoma, \-- completely treated in-situ cervical carcinoma, or \-- completely treated basal cell carcinoma. 11. Chronic use of systemic glucocorticoids or other immunosuppressives, or biologic immunomodulators. Living Donor: Living donors who meet the following criteria will not be eligible for this study: <!-- --> 1. Any condition that, in the opinion of the investigator, may pose additional risks from participation in the study, may: -- interfere with the participant's ability to comply with study requirements or --impact the quality or interpretation of the data obtained from the study. Deceased Donor: Recipients of livers from deceased donors who meet the following criteria are ineligible for this study: 1\. Any condition that, in the opinion of the investigator, may pose additional risks or may impact the quality or interpretation of the data obtained from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Massachusetts General Hospital: Transplantation
Boston, Massachusetts, 02114, United States
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