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| Name | Class |
|---|---|
| GC Biopharma Corp | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Singe-dose infusion | Experimental | Cohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg |
|
| Repeated dose infusion | Experimental | Cohort 3: 1x10^6 cells/kg Cohort 4: 3x10^6 cells/kg Cohort 5: 1x10^7 cells/kg Cohort 6: 3x10^7 cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic NK cells | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the MTD of allogenetic NK cells | DLT is defined as follows:
| 4-5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the overall response rate | RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma | 4-5 weeks |
| To evaluate the safety | NCI-CTCAE v3.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| 4 -5 weeks |
| To evaluate the pharmacokinetics of allogeneic NK cells | To quantify the persistence of donor NK cells in recipients | 4-5 weeks |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |