Study Summary
This trial is exploring whether a cell therapy can help people with liver transplants stop taking immunosuppressive drugs.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 7 Secondary · Reporting Duration: Post-transplant through Completion of Study Participation (Up to 4.5 years)
Week 4
Number of Operationally Tolerant Participants
Year 5
Number of Participants who Develop a Malignancy
Year 5
Incidence of ≥Grade 3 Infections Following arTreg Infusion
Investigational New Drugs
Number of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at any Time after Alloantigen-Reactive Tregs (arTreg) Infusion
Number of Chronic Rejection Events at Any Time after Alloantigen-Reactive Tregs (arTreg) Infusion
Severity of Biopsy-Proven Acute Rejection (AR) and/or Clinical Rejection Events at any Time after Alloantigen-Reactive Tregs (arTreg) Infusion
Year 5
Number and Severity of Adverse Events (AEs) Attributed to Supportive Regimen: Leukapheresis, Cyclophosphamide or Mesna
Year 5
Duration of Operational Tolerance
Tacrolimus
Trial Safety
Trial Design
1 Treatment Group
arTreg
1 of 1
Experimental Treatment
9 Total Participants · 1 Treatment Group
Primary Treatment: arTreg · No Placebo Group · Phase 1 & 2
arTregExperimental Group · 5 Interventions: arTreg, cyclophosphamide, leukapheresis, everolimus, mesna · Intervention Types: Biological, Drug, Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
leukapheresis
2004
Completed Phase 3
~230
Everolimus
FDA approved
Coenzyme M
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-transplant through completion of study participation (up to 4.5 years)
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,151 Previous Clinical Trials
4,770,865 Total Patients Enrolled
PPDIndustry Sponsor
148 Previous Clinical Trials
31,533 Total Patients Enrolled
Rho Federal Systems Division, Inc.Industry Sponsor
39 Previous Clinical Trials
15,244 Total Patients Enrolled
Immune Tolerance Network (ITN)NETWORK
67 Previous Clinical Trials
7,890 Total Patients Enrolled
Sandy Feng, MD, PhDStudy ChairUniversity of California, San Francisco
1 Previous Clinical Trials
15 Total Patients Enrolled
Eligibility Criteria
Age 18 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a history of hepatitis C virus (HCV) infection and completed treatment for HCV, maintaining a sustained viral response of ≥24 weeks duration by the day of transplant.
You meet donor eligibility manufacturing requirements within 7 days before or after the blood collection for manufacturing.
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Conditions
Cancer Related
Treatments