Last updated on June 2019

Phase 1-2 MAHCT w/ TCell Depleted Graft w/ Simultaneous Infusion Conventional and Regulatory T Cell

Brief description of study

For patients with hematologic malignancies undergoing allogeneic myeloablative (MA) HCT with a T cell depleted graft, the infusion of naturally occurring regulatory T cells with conventional T cells (T cell add back) in pre-defined doses and ratios will reduce the incidence of acute graft vs host disease while augmenting the graft vs leukemia effect and improving immune reconstitution.

Detailed Study Description

Primary Objectives:

  • To determine the efficacy, safety and feasibility of administration of several dose combinations of conventional T cells (Tcon) and regulatory T cells (Treg) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) with HLA matched donors (related or unrelated) using a T cell depleted graft [CD34+ hematopoietic progenitor cells ("CD34+ HSPC")], without immune suppression.
  • To determine the maximum tolerated dose of infused regulatory and conventional T cells in the matched donor setting
  • To determine 1 year event free survival (EFS) post HCT

Secondary Objectives:

  • To determine the 1 year OS in patients undergoing allogeneic HCT with matched donors.
  • To measure the incidence and severity of acute and chronic graft vs host disease (GvHD)
  • To measure incidence of serious infections

Clinical Study Identifier: NCT01660607

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