Safety and Preliminary Efficacy of Donor-derived Regulatory Dendritic Cell (DCreg) Infusion and Immunosuppression Withdrawal in Living Donor Liver Transplantation

STUDY19020267

Phase I/II, single center, prospective, open-label, non-controlled, non-randomized, interventional, cohort study in which low risk living donor liver transplant (LDLT) recipients will receive a single infusion of donor-derived DCreg 1 week prior to transplantation. All patients will be maintained on MPA and Tacrolimus (Tac) for the 1st 6 months after transplantation. At that time point, recipients meeting specific criteria will be slowly weaned off MPA per standard of care over a period of 6 months. Participants will then be evaluated for TAC weaning at 1 yr after transplantation. Those who meet specific criteria be weaned off Tac over 6 months . Successfully weaned participants who remain rejection-free will undergo 3 years of follow-up after the last dose of immunosuppression.

2017-08-30

2024-12-01

2024-12-01

Active (not recruiting)

Early phase I

16

Inclusion Criteria: Donors 1. Able to understand and provide informed consent; 2. Male or female between the ages of 18-55; 3. Meet all standard institutional and UNOS criteria for liver donation; 4. For females of childbearing potential, a negative urine or serum pregnancy test; 5. Negative for HIV (5th generation Test and NAT), HTLV-1, HTLV-2;(\*) 6. Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and NAT)(\*) Recipients 1. Low risk recipient approved for LDLT, irrespective of gender, race, or ethnic background. Low risk is defined by absence of exclusion criteria (below). 2. Between ages 18 and 65 years 3. Undergoing de novo (first) liver transplant 4. Female subjects of childbearing potential must have a negative pregnancy test upon study entry. 5. 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 participants of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used from the time that study treatment begins until 1 year after completion of immunosuppression withdrawal. (\*)does not preclude donors from undergoing leukapheresis but cells may not be infused into recipient.

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2023-09-13