NCT01212341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

August 19, 2013

Status Verified

August 1, 2013

Enrollment Period

1.9 years

First QC Date

September 18, 2010

Last Update Submit

August 15, 2013

Conditions

Malignant LymphomasSolid Tumors

Keywords

Allogenetic NK cellsLymphomasSolid tumors

Outcome Measures

Primary Outcomes (1)

  • To determine the MTD of allogenetic NK cells

    DLT is defined as follows: * Any toxicity at grade 3 or over for 5 days or more * All grade 4 toxicities * GVHD at grade 2 or over

    4-5 weeks

Secondary Outcomes (3)

  • To determine the overall response rate

    4-5 weeks

  • To evaluate the safety

    4 -5 weeks

  • To evaluate the pharmacokinetics of allogeneic NK cells

    4-5 weeks

Study Arms (2)

Singe-dose infusion

EXPERIMENTAL

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

Biological: Allogeneic NK cells

Repeated dose infusion

EXPERIMENTAL

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

Biological: Allogeneic NK cells

Interventions

Allogeneic NK cellsBIOLOGICAL
Repeated dose infusionSinge-dose infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2010

First Posted

September 30, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2012

Study Completion

March 1, 2013

Last Updated

August 19, 2013

Record last verified: 2013-08

Locations

KR(1)