Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction
United States15 participantsStarted 2016-06-06
Plain-language summary
This research study is for liver transplant recipients and their respective living donors.
The purpose of this study is:
1. To see if it is safe for liver recipients to receive one dose of donor reactive T regulatory cells (Tregs)
2. To see if the Tregs allows a liver recipient to take less, or completely stop medications normally taken after receiving an organ transplant.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able to understand and provide informed consent
. Have received a primary, solitary, living donor liver transplant more 24 months and less than 84 months ago
. Have a living donor who is willing to consent to a one time blood draw of 100 mLs to enable the manufacture of Donor Alloantigen Reactive Regulatory T cells (darTregs)
. Eighteen to 70 years of age at the time of study entry/consent
. Liver function test (LFT) results: have Alanine Aminotransferase (ALT)consistently \<60 U/L and either alkaline phosphatase consistently \<150 U/L or Gamma-glutamyl transferase (GGT) consistently \<60 U/L
. Currently receiving a Calcineurin Inhibitor (CNI) with 12 hour trough levels consistently \<6.0 ng/mL for tacrolimus; \<150 ng/mL for cyclosporine
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experienced Grade 3 or Higher Adverse Events (AEs) Deemed Attributable to darTreg Infusion
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion
2
Number of Participants With Study Defined Grade 3 or Higher Infections
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion
3
Number of Participants With Any Malignancy
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion
4
Proportion of Liver Transplant Recipients Who Are Able to Reduce Calcineurin Inhibitor Dosing by 75 Percent and Discontinue a Second Immunosuppression Drug (if Applicable) With Stable Liver Function Tests (LFTs) for ≥ 12 Weeks
Timeframe: From initiation of immunosuppression withdrawal to 24 weeks after darTregs infusion
Trial details
NCT IDNCT02474199
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Currently receiving CNI monotherapy or CNI and one of the following:
. Prednisone: maximum dose of 5mg daily
Exclusion criteria
. Transplant for liver disease secondary to autoimmune disease (e.g. autoimmune hepatitis, primary sclerosing cholangitis, or primary biliary cirrhosis)
. Matched at both human leukocyte antigen (HLA)-DR loci to the donor
. Organ, tissue or cell transplant prior to or after the primary solitary living donor liver transplant
. For subjects with hepatitis B, detectible hepatitis B virus (HBV) DNA
. History of malignancy within 5 years of enrollment. History of adequately treated in-situ cervical carcinoma and/or skin cancer (basal or squamous cell) will be permitted.
. Serologic evidence of human immunodeficiency 1 or 2 infection
. Epstein Barr Virus (EBV) seronegativity (EBV naïve) if living donor is EBV seropositive
. Cytomegalovirus (CMV) seronegativity (CMV naïve) if living donor is CMV seropositive