Liver Transplantation With Tregs at UCSF

"Eligible participants will receive a single dose of Treg product (arTreg). The target dose is at least 90 x 10\^6 total cells.~Method of receipt: peripheral intravenous (IV) infusion, administered over 20 to 30 minutes."

"Leukapheresis will be the method employed to recover peripheral blood mononuclear cells (PBMCs) from the allograft recipient. The recipient will undergo the procedure prior to initiating the cyclophosphamide conditioning regimen.~Procedure on Day -3 (-1 day) prior to Treg product (arTreg) IV infusion."

40 mg/kg administered intravenously (IV) following leukapheresis and between 1 to 3 days prior to Treg product (arTreg) infusion, per institutional standard of care.

"Mesna is administered:~* Intravenously to inhibit hemorrhagic cystitis induced by cyclophosphamide, and~* In conjunction with the cyclophosphamide, per institutional practice with CTX."

EVR is approved for prophylaxis of allograft rejection in adults receiving a liver transplant. Per protocol: Post transplantation, subject will initially receive standard IS with tacrolimus (TAC),plus a mycophenolate product and/or steroids.Subsequently, evaluation for eligibility to be converted to EVR-based IS regimen will occur and, when applicable, proceed. Once the optimal EVR trough level is achieved,TAC dose will be reduced. When target EVR and TAC levels are maintained over two consecutive measurements, ALT liver function test (LFT) is ≤50 U/L, GGT LFT is ≤ the upper limit of normal or ≤ 1.5 times the baseline GGT, subject will be considered successfully converted to EVR-based IS regimen. EVR doses will be administered/monitored/adjusted over time.