Safety Trial of NK Cell Donor Lymphocyte Infusions From 3-5/6 HLA Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation
The use of non-selected donor lymphocyte infusions (DLIs) (to help early immune recovery and
induce antitumor response) following nonmyeloablative allogeneic stem cell transplantation
is also complicated by the risk of acute graft versus host disease (aGVHD) with 30-40% of
patients experiencing grade III-IV aGVHD. Data suggests that the use of natural killer (NK)
cells (instead of nonselected DLIs) in this setting may mediate a GVT effect independently
This pilot study is designed to evaluate the feasibility and toxicity of donor natural
killer (NK) cell selection and infusion following nonmyeloablative allogeneic stem cell
transplantation from mismatched donors. Additionally, we will assess immune
reconstitution/function post NK cell infusion and evaluate efficacy.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the safety of NK cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplantation from mismatched donors: toxicity including mortality, occurrence of acute GVHD and other severe toxicity.
David Rizzieri, MD
Duke University Health Systems
United States: Food and Drug Administration
|Duke University Health Systems||Durham, North Carolina 27710|