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CompletedNCT00846833Updated Jun 8, 2012

Haploidentical NK Cell Infusion in Malignant Melanoma

A Phase 1/2 interventional study of Haploidentical NK cell in Melanoma, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-08.

Sponsored by Seoul National University Hospital · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Melanoma

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Keywords

  • Melanoma, Experimental
03

In context

Melanoma

3,073 studies on the registry are indexed under Melanoma; 529 are open to participants now.

This study's planned enrollment of 12 is below the median of 38 across 2,400 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 mL/min/1.73m2
  • At least 3 months of expected survival
  • Patients who signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients who received other chemotherapeutic agents within 30 days prior to study enrollment
  • Patients who received adoptive cell therapy including hematopoietic stem cell transplantation
  • 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 agents
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Cyclophosphamide, high-dose interleukin-2, NK cell

    Biological: Haploidentical NK cell

Interventions

  • BiologicalHaploidentical NK cell

    1. Collection of PBMCs by leukapheresis 2. CD3+ depletion of apheresis product using CliniMACS®

06

What researchers measure

Primary outcomes

  1. To determine the maximum-tolerated dose of haploidentical NK cells

    Time frame: 1 year

Secondary outcomes

  1. To assess NK cell infusion-related toxicity

    Time frame: 2 years

  2. To evaluate response rate

    Time frame: 2 years

  3. To determine immune reconstitution after NK cell infusion

    Time frame: 2 years

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, South Korea
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2009, a primary completion of Feb 2011 and a completion of Apr 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2009
First posted
Feb 19, 2009
Start
Feb 2009
Primary completionActual
Feb 2011
CompletionActual
Apr 2012
Last update
Jun 8, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00846833
Lead sponsor
Seoul National University Hospital
First posted
Feb 19, 2009
Start date
Feb 2009
Primary completion
Feb 2011
Completion
Apr 2012
Last update
Jun 8, 2012

Study contacts

Dae Seog Heo, Professor
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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