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

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling

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Trial Information

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.

Inclusion Criteria:

- Histologically confirmed metastatic or relapsed malignant melanoma

- Patients who received prior chemotherapy or immunotherapy

- Patients who have at least one haploidentical donor willing to donate

- ECOG performance status 0 or 1

- 18 - 75 years

- At least one measurable disease according to the RECIST criteria

- Patients with 45% or more left ventricular ejection fraction

- Patients with 50% or more predicted DLCO

- Adequate bone marrow function: absolute neutrophil count ≥ 1.5 x 109/L; platelet
count ≥ 100 x 109/L; and hemoglobin ≥ 9 g/dL

- Adequate liver function: total bilirubin ≤ 1.0 x upper limit of the normal range
(ULN); AST/ALT ≤ 2.5 x ULN; and alkaline phosphatase ≤ 2.5 x ULN

- Adequate renal function: serum creatinine ≤ 1.0 x ULN or creatinine clearance ≥ 60

- At least 3 months of expected survival

- Patients who signed informed consent

Exclusion Criteria:

- Patients who received other chemotherapeutic agents within 30 days prior to study

- Patients who received adoptive cell therapy including hematopoietic stem cell

- Patients infected with HIV, HBV, or HCV

- Hypersensitivity to cyclophosphamide or interleukin-2

- Patients who received organ transplantation

- Patients who had arrhythmia or ischemic heart disease

- Pregnant or lactating women

- Patients with uncontrolled infection who did not respond to appropriate antimicrobial

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum-tolerated dose of haploidentical NK cells

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Dae Seog Heo, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital


South Korea: Institutional Review Board

Study ID:




Start Date:

February 2009

Completion Date:

April 2012

Related Keywords:

  • Melanoma
  • Melanoma, Experimental
  • Melanoma