Liver Transplantation With Tregs at MGH (NCT03577431) | Clinical Trial Compass
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 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
. 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)
. 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
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 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)
2
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)
3
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)
4
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)
5
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)
. 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