Haploidentical Stem Cell Transplantation and IL-15 NK Cell Infusion for Paediatric Refractory Solid Tumours
The investigators propose a new antitumor cell therapy for treating childhood refractory
solid tumours. The aim of this study is explore the graft versus tumour effect mediated by
allogenic natural killer cells (NKs). NK cell alloreactivity can be predicted by donor
killer immunoglobulin-like receptors (KIRs) and human leukocyte antigen (HLA) class I
alleles mismatch. Cells without an inhibitory HLA ligand may trigger natural killer cell
activation and elimination of those target cells. Reduced risk of relapsed has been
described in malignant cancer after haploidentical stem cell transplantation when HLA
ligands against the inhibitory KIRs present in the donor were absent in the recipient
(KIR-HLA receptor-ligand mismatch). NK alloreactivity could also be obtained by Natural
Killer Receptor (NCR), Toll-Like-Receptors (TLRs) and NKG2D receptor stimulation mediated by
cytokines or tumour cell lines.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of patients with adverse events according to NCI-CTC v3.0 CRITERIA as a measure of safety and tolerability
Up To 1 Year After Transplantation
Yes
ANTONIO PEREZ-MARTINEZ, MD, PhD
Principal Investigator
HOSPITAL UNIVERSITARIO NINO JESUS
Spain: Spanish Agency of Medicines
HNJ-NK-01/2009
NCT01337544
January 2011
January 2014
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