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

Seoul National University Hospital18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Lymphomas Solid Tumors

Interventions

Allogeneic NK cellsBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: 4-5 weeks

Secondary Outcomes

To determine the overall response rate

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

Time frame: 4-5 weeks

To evaluate the safety

NCI-CTCAE v3.0

Time frame: 4 -5 weeks

To evaluate the pharmacokinetics of allogeneic NK cells

To quantify the persistence of donor NK cells in recipients

Time frame: 4-5 weeks

Data from ClinicalTrials.gov

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