Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation

Stopped early · Phase 1

Conditions studied: Liver Transplantation

In brief

The purpose of this study is look at the safety of: * Taking a specific combination of immunosuppressant drugs after liver transplantation * Receiving one of three different doses of donor-alloantigen-reactive regulatory T cells (darTregs) while taking this specific combination of drugs

Key facts

Study ID

NCT02188719

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

15

Starts

2014-12-17

Expected to finish

2019-06-18

Last updated by the study team

2020-09-22

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who meet all of the following criteria are eligible for enrollment as study participants:
• Able to understand and provide informed consent
• End-stage liver disease and listed for primary solitary liver transplant
• Have a calculated Model for End Stage Liver Disease (MELD) score ≤ 25 at the time of study entry/consent
• Female and male subjects with reproductive potential must agree to use effective methods of birth control for the duration of the study.
• If history of Hepatitis C Virus (HCV), have completed or are in current treatment for HCV AND have no detectable HCV RNA.
• Subjects with HCC meeting Milan criteria.

You may not qualify if…

• Below are exclusion criteria to be assessed at study enrollment, prior to Stage 1 study procedures. Subjects who meet any of these criteria are not eligible for Stage 1 study procedures. Note that subjects in Cohort 1a or 1b will NOT undergo leukapheresis regardless of eligibility.
• End stage liver disease secondary to autoimmune etiology (autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis)
• History of less than 5 years remission of malignancy, except for 1) HCC or 2) history of adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin.
• History of previous organ, tissue or cell transplant
• Serologic evidence of human immunodeficiency (HIV) 1 or -2 infection
• Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) sero-negativity (EBV or CMV naïve candidates)
• Chronic use of systemic glucocorticoids or other Immunosuppression (IS), or biologic immunomodulators
• Chronic condition requiring anti-coagulation after liver transplantation
• Any chronic illness or prior treatment which, in the opinion of the investigator, precludes study participation
• Participation in any other studies that involved investigational drugs or regimens in the preceding year
• Received any vaccination within 28 days prior to leukapheresis or blood collection for Treg manufacture
• Hemoglobin <9.0 g/dL within 10 days prior to screening
• Neutrophils <1,500/μL within 10 days prior to screening
• Platelets <40,000/μL within 10 days prior to screening
• Thymoglobulin Exclusion Criteria B (Stage 2):
• Below are exclusion criteria to be assessed prior to administration of Thymoglobulin®. Subjects who meet any of these criteria should not receive Thymoglobulin®:
• Calculated Model for End Stage Liver Disease (MELD) score >25 at the time of deceased donor liver transplant
• Last alpha-fetoprotein (AFP) obtained prior to liver transplantation >400 μg/L for candidates with Hepatocellular Carcinoma (HCC)
• Unacceptable Peripheral Blood Mononuclear Cells (PBMC) product for participants enrolled in Cohorts 2, 3, or 4 per the UCSF The Human Islet and Cellular Transplant Facility (HICTF) manufacturing specifications
• Absence of donor spleen for any participants
• Human leukocyte antigen (HLA)-DR (DR is one of class II antigens) matched to donor at both loci
• Subject is < 21 or >70 years of age at the time of transplantation
• Located in the intensive care unit 72 hours after transplantation
• Hemoglobin <8.0 g/dL
• Absolute neutrophil count <1,200/μL

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Northwestern University — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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