Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation

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.

Timeline

Start

2013-04

Primary completion

2018-03-15

Completion

2018-03-15

Publications

• Results Devillier R, Calmels B, Guia S, Taha M, Fauriat C, Mfarrej B, Venton G, Vivier E, Olive D, Chabannon C, Blaise D, Ugolini S. Phase I Trial of Prophylactic Donor-Derived IL-2-Activated NK Cell Infusion after Allogeneic Hematopoietic Stem Cell Transplantation from a Matched Sibling Donor. Cancers (Basel). 2021 May 28;13(11):2673. doi: 10.3390/cancers13112673.
• Results Mfarrej B, Gaude J, Couquiaud J, Calmels B, Chabannon C, Lemarie C. Validation of a flow cytometry-based method to quantify viable lymphocyte subtypes in fresh and cryopreserved hematopoietic cellular products. Cytotherapy. 2021 Jan;23(1):77-87. doi: 10.1016/j.jcyt.2020.06.005. Epub 2020 Jul 25.

Drugs

Indications