Back to results

Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor (MG4101)

Primary Purpose

Malignant Lymphomas, Solid Tumors

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Allogeneic NK cells

About this trial

This is an interventional treatment trial for Malignant Lymphomas focused on measuring Allogenetic NK cells, Lymphomas, Solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Singe-dose infusion

Repeated dose infusion

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine the overall response rate

RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma

To evaluate the safety

NCI-CTCAE v3.0

To evaluate the pharmacokinetics of allogeneic NK cells

To quantify the persistence of donor NK cells in recipients

Full Information

NCT ID

NCT01212341

First Posted

September 18, 2010

Last Updated

August 15, 2013

Sponsor

Seoul National University Hospital

Collaborators

GC Biopharma Corp

1. Study Identification

Unique Protocol Identification Number

NCT01212341

Brief Title

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

Acronym

MG4101

Official Title

A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

Collaborators

GC Biopharma Corp

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Lymphomas, Solid Tumors

Keywords

Allogenetic NK cells, Lymphomas, Solid tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Singe-dose infusion

Arm Type

Experimental

Arm Description

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

Arm Title

Repeated dose infusion

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Allogeneic NK cells

Primary Outcome Measure Information:

Title

To determine the MTD of allogenetic NK cells

Description

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

Time Frame

4-5 weeks

Secondary Outcome Measure Information:

Title

To determine the overall response rate

Description

RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma

Time Frame

4-5 weeks

Title

To evaluate the safety

Description

NCI-CTCAE v3.0

Time Frame

4 -5 weeks

Title

To evaluate the pharmacokinetics of allogeneic NK cells

Description

To quantify the persistence of donor NK cells in recipients

Time Frame

4-5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs