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

Phase 1 Terminated 15 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Rho Federal Systems Division, Inc. · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2014-12-17
Primary completion: 2019-06-18
Completion: 2019-06-18

Outcome

Outcome not reported

Stopped: “The trial could not be completed within the grant timeline.”

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	darTreg Infusion	Unknown	50 cells	—
Subject	darTreg Infusion	Unknown	200 cells	—
Subject	darTreg Infusion	Unknown	800 cells	—
Background	Acetaminophen	Small molecule	650 mg	Intravenous
Background	Anti-Infective Prophylaxis	Unknown	—	Oral
Background	Diphenhydramine	Small molecule	25 mg	Intravenous
Background	Diphenhydramine	Small molecule	50 mg	Intravenous
Background	Everolimus	Small molecule	—	—
Background	Ganciclovir	Small molecule	—	Intravenous
Background	Mycophenolate Mofetil	Small molecule	1000 mg	—
Background	Prednisone	Other / unclassified	—	—
Background	Tacrolimus	Small molecule	—	—
Background	rabbit anti-thymocyte globulin	Protein / enzyme biologic	1.5 mg/kg	Intravenous

Indications

No indication recorded.