Description
The objectives for the study are listed below:
Primary Objectives
*Determine the safety, and feasibility of administration of several dose combinations of conventional T-cells (Tcon) and regulatory T-cells (Treg) in subjects undergoing allogeneic hematopoietic cell transplantation (HCT) with related/unrelated HLA-matched or mismatched donors, or haploidentical donors with reduced intensity conditioning preparative regimen.
Secondary Objectives
* To determine the GVHD-free relapse-free survival (GRFS) post-HCT
* To determine the overall survival (OS) post-HCT
* To measure the incidence and severity of acute and chronic GVHD
Exploratory Objectives
* To measure the incidence of serious infections
* To measure the incidence and timing of engraftment
* To measure T cell immunity reconstitution parameters