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Completed

NCT Number: NCT01212341

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

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.

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Key information

Conditions

Malignant Lymphomas Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allogeneic NK cells

Biological

Primary outcomes

  1. To determine the MTD of allogenetic NK cells

    Time frame: 4-5 weeks

    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 outcomes

  1. To determine the overall response rate

    Time frame: 4-5 weeks

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

  2. To evaluate the safety

    Time frame: 4 -5 weeks

    NCI-CTCAE v3.0

  3. To evaluate the pharmacokinetics of allogeneic NK cells

    Time frame: 4-5 weeks

    To quantify the persistence of donor NK cells in recipients

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • GC Biopharma Corp

Registry information

Official study title

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

Acronym: MG4101

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Sep 30, 2010
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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