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Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation
Sponsor: Institut Paoli-Calmettes
Summary
The goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.
Official title: Phase I of Infusion of Selected Donor NK Cells After HLA Identical Allogeneic Stem Cell Transplantation Prepared With Reduced Intensity Conditioning - DLI-NK/IPC 2012-003
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2013-04
Completion Date
2018-03-15
Last Updated
2026-04-21
Healthy Volunteers
No
Conditions
Interventions
NK Cell infusion
* level 1: 1 x 10e6 NK cells /kg; * level 2: 5 x 10e6 NK cells /kg; * level 3: \> 5.10e6 and ≤ 5.10e7 cellules NK/kg
Locations (1)
Institut Paoli-Calmettes
Marseille, France