Clinical Trial: Haploidentical NK Cell Infusion in Malignant Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I/II Study of Haploidentical Natural Killer Cell Infusion in Patients With Refractory or Relapsed Malignant Melanoma

Brief Summary: We hypothesized that haploidentical NK cells kill tumor cells more efficiently than autologous NK cells, based on the missing-self hypothesis. Therefore, we performed this study to investigate the role of haploidentical NK cell therapy in patients with refractory or relapsed malignant melanoma.

Detailed Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: To determine the maximum-tolerated dose of haploidentical NK cells [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess NK cell infusion-related toxicity [ Time Frame: 2 years ]
  • To evaluate response rate [ Time Frame: 2 years ]
  • To determine immune reconstitution after NK cell infusion [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Seoul National University Hospital

Dates:
Date Received: February 17, 2009
Date Started: February 2009
Date Completion:
Last Updated: June 6, 2012
Last Verified: June 2012