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

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)

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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