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Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor

NCT ID: NCT01212341

Last Updated: 2013-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.

Detailed Description

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Conditions

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Malignant Lymphomas Solid Tumors

Keywords

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Allogenetic NK cells Lymphomas Solid tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Singe-dose infusion

Cohort 1: 1x10\^6 cells/kg Cohort 2: 1x10\^7 cells/kg

Group Type EXPERIMENTAL

Allogeneic NK cells

Intervention Type BIOLOGICAL

Repeated dose infusion

Cohort 3: 1x10\^6 cells/kg Cohort 4: 3x10\^6 cells/kg Cohort 5: 1x10\^7 cells/kg Cohort 6: 3x10\^7 cells/kg

Group Type EXPERIMENTAL

Allogeneic NK cells

Intervention Type BIOLOGICAL

Interventions

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Allogeneic NK cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Age 18 years or older
* Histologically or cytologically confirmed malignant lymphoma or solid tumor
* After the failure of standard treatment
* KPS \>70 or ECOG PS 0-2
* Adequate bone marrow, renal, and liver functions
* Expected survival at least 3 months
* Informed consent

Exclusion Criteria

* Pregnancy or lactating woman
* HIV patients
* Prior exposure to cell-based therapy
* Hypersensitivity to interleukin-2
* Patients with autoimmune disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GC Biopharma Corp

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MG4101_P1

Identifier Type: -

Identifier Source: org_study_id