Malignant Lymphomas, Solid Tumors
Conditions
Keywords
Allogenetic NK cells, Lymphomas, Solid tumors
Brief summary
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.
Interventions
BIOLOGICALAllogeneic NK cells
Sponsors
GC Biopharma Corp
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the MTD of allogenetic NK cells | 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
| Measure | Time frame | Description |
|---|---|---|
| To determine the overall response rate | 4-5 weeks | RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma |
| To evaluate the safety | 4 -5 weeks | NCI-CTCAE v3.0 |
| To evaluate the pharmacokinetics of allogeneic NK cells | 4-5 weeks | To quantify the persistence of donor NK cells in recipients |
Countries
South Korea
Outcome results
None listed