Active — Not RecruitingPhase 1/2

Liver Transplantation With Tregs at MGH

United States9 participantsStarted 2019-03-29

Plain-language summary

This is a single-center, prospective, open-label, non-randomized clinical trial exploring cellular therapy to facilitate immunosuppression withdrawal in liver transplant recipients.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Able to understand and provide informed consent
✓. End-stage liver disease and listed for a living or deceased-donor primary solitary liver transplant
✓. Agreement to use contraception
✓. Positive Epstein-Barr virus (EBV) antibody test and
✓. 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)
✓. Able to understand and provide informed consent
✓. Meets site-specific clinical donor eligibility requirements
✓. Meets donor eligibility manufacturing requirements within 7 days prior to blood collection for manufacturing and

Exclusion criteria

✕. History of previous organ, tissue or cell transplant requiring or potentially requiring immunosuppression
✕. For cytomegalovirus (CMV) antibody negative recipients, a (CMV) antibody positive donor
✕. Known contraindication to cyclophosphamide or Mesna administration
✕. Serologic evidence of human immunodeficiency virus (HIV)-1/2 infection
✕. The need for chronic anti-coagulation that cannot be safely discontinued for a minimum of 1 week to safely perform a liver biopsy
✕. End stage liver disease secondary to autoimmune etiology (autoimmune hepatitis, primary biliary cirrhosis, or primary sclerosing cholangitis) or other contraindications to drug withdrawal
✕. Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
✕. Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may interfere with study compliance

What they're measuring

Number of Adverse Events (AEs) Attributed to the Investigational Product, arTreg-CSB

Timeframe: From arTreg-CSB infusion through completion of study participation (Up to 4.5 years)

Severity of Adverse Events (AEs) Attributed to the Investigational Product, arTreg-CSB

Timeframe: From arTreg-CSB infusion through completion of study participation (Up to 4.5 years)

Number of Adverse Events (AEs) Attributed to the Investigational Product's Supportive Regimen (Leukapheresis, Cyclophosphamide and Mesna)

Timeframe: From ≤3 days prior to arTreg-CSB infusion through completion of study participation (Up to 4.5 years)

Severity of Adverse Events (AEs) Attributed to the Investigational Product's Supportive Regimen (Leukapheresis, Cyclophosphamide and Mesna)

Timeframe: From ≤3 days prior to arTreg-CSB infusion through completion of study participation (Up to 4.5 years)

Number of Operationally Tolerant Participants

Timeframe: 52 weeks (±4 weeks) after the last dose of immunosuppression

Trial details

NCT IDNCT03577431

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2026-02-06

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