NCT01163201 — drugset

Summary

This is a unique dose-escalation trial that will titrate doses of umbilical cord blood (UCB) Treg and CD3+ Teff cells with the goal of infusing as many CD3+ Teff cells as possible without conferring grade II-IV acute graft-versus-host disease (GVHD). In this study, the investigators propose to add UCB Treg and UCB CD3+ Teff cells to the two TCD UCB donor units with the goal of transplanting as many CD3+ Teff cells as possible without reintroducing risk of acute GVHD. The investigators hypothesize that Treg will permit the reintroduction of CD3+ Teff cells that will provide a bridge while awaiting HSC T cell recovery long term. The co-infusion of Treg will prevent GVHD without the need for prolonged pharmacologic immunosuppression.

Timeline

Start: 2014-01
Primary completion: 2015-01
Completion: 2015-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CD3+ Teff cells	Cell therapy	3e+06 cells/kg	Other
Subject	CD3+ Teff cells	Cell therapy	6e+06 cells/kg	Other
Subject	CD3+ Teff cells	Cell therapy	9e+06 cells/kg	Other
Subject	CD3+ Teff cells	Cell therapy	1.2e+07 cells/kg	Other
Subject	CD3+ Teff cells	Cell therapy	1.5e+07 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	3e+06 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	1e+07 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	3e+07 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	1e+08 cells/kg	Other
Subject	Regulatory T cells	Cell therapy	3e+08 cells/kg	Other
Background	Cyclophosphamide	Other / unclassified	60 mg/kg	Intravenous
Background	Fludarabine	Small molecule	25 mg/m2	Intravenous
Background	Umbilical cord blood transplantation	Cell therapy	—	Other

T-Regulatory Cell and CD3 Depleted Double Umbilical Cord Blood Transplantation in Hematologic Malignancies

Summary

Timeline

Drugs

Indications