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

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Seoul National University

Status and phase

Completed
Phase 1

Conditions

Malignant Lymphomas
Solid Tumors

Treatments

Biological: Allogeneic NK cells

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01212341
MG4101_P1

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Singe-dose infusion
Experimental group
Description:
Cohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg
Treatment:
Biological: Allogeneic NK cells
Repeated dose infusion
Experimental group
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
Treatment:
Biological: Allogeneic NK cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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