Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma
Human NK cells recognize and kill transformed cells in a MHC-unrestricted fashion,
suggesting the role of cancer immunotherapy. However, autologous NK cells showed the lack of
significant clinical effects, because they are inhibited by self MHC class I molecules,
based on the missing-self hypothesis. Contrarily, haploidentical NK cells with KIR-ligand
incompatibility can mediate graft-versus-leukemia effect and protect patients with acute
myelogenous leukemia (AML) from graft-versus-host disease. In addition, adoptive transfer of
haploidentical NK cells following high-intensity conditioning induced complete remission
(26%) in poor-prognosis AML patients. Thus, this study was designed to investigate the role
of adoptive NK cell therapy in patients with refractory or relapsed malignant melanoma using
CD3+ depleting CliniMACS® system.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum-tolerated dose of haploidentical NK cells
1 year
Yes
Dae Seog Heo, Professor
Principal Investigator
Seoul National University Hospital
South Korea: Institutional Review Board
H-0808-024-253
NCT00846833
February 2009
April 2012
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