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 range18 Years – 70 Years
SexALL
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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
✓. 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
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)
. 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