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Phase I Study of Random Healthy Donor-Derived Allogeneic Natural Killer Cell Therapy in Patients with Malignant Lymphoma or Advanced Solid Tumors.

Author information

Affiliations

  • 1. Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea. Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
      Authors
    • Yang Y 1
    • Kim TM 1
    • Keam B 1
    • Lee SH 1
    • Kim DW 1
    • Heo DS 1
    (6 authors)
  • 2. Cell Therapy Team, MOGAM Biotechnology Institute, Yongin, Gyeonggi-do, Korea.
      Authors
    • Lim O 2
    • Choi H 2
    • Chung H 2
    • Min B 2
    • Her JH 2
    • Cho SY 2
    • Hwang YK 2
    (7 authors)
  • 3. Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
      Authors
    • Ahn YO 3
    (1 author)

ORCIDs linked to this article

Cancer Immunology Research, 19 Jan 2016, 4(3):215-224
https://doi.org/10.1158/2326-6066.cir-15-0118 PMID: 26787822 

Abstract 

Natural killer (NK) cells with mismatched killer cell immunoglobulin-like receptor-ligand pairs have shown efficacy and been proven safe in treatment of cancer patients. Ex vivo-expanded and highly activated NK cells (MG4101) had been generated under good manufacturing practice conditions, which demonstrated potent anticancer activity in vitro and in vivo in preclinical studies. The current phase I clinical trial was designed to evaluate safety and possible clinical efficacy of repetitive administrations of MG4101 derived from random unrelated healthy donors into patients with malignant lymphoma or advanced, recurrent solid tumors. The maximum dose (3 × 10(7) cells/kg, triple infusion) was tolerable without significant adverse events. Of 17 evaluable patients, 8 patients (47.1%) showed stable disease and 9 (52.9%) showed progressive disease. We also evaluated the capacity of MG4101 to influence host immune responses. Administration of MG4101 augmented NKG2D expression on CD8(+) T cells and upregulated chemokines that recruit T cells. In contrast, administration of MG4101 reduced regulatory T cells and myeloid-derived suppressor cells and suppressed TGFβ production. In conclusion, administration of a large number of MG4101 cells was not only safe and feasible, but also exhibited efficacy in maintaining the effector arm of the host immune response.

Full text links 

Read article at publisher's site: https://doi.org/10.1158/2326-6066.cir-15-0118

Read article for free, from open access legal sources, via Unpaywall: https://figshare.com/articles/journal_contribution/Supplementary_Tables_S1_S2_from_Phase_I_Study_of_Random_Healthy_Donor_Derived_Allogeneic_Natural_Killer_Cell_Therapy_in_Patients_with_Malignant_Lymphoma_or_Advanced_Solid_Tumors/22538485Unpaywall

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Funding 

Funders who supported this work.

Green Cross Corporation,MOGAM Biotechnology Institute, and the Innovative Research Institute for Cell Therapy, Republic of Korea (1)