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This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.
This is a first-in-human, open-label, non-randomized, dose-escalation and expansion phase 1/2a trial to determine the safety profile and identify the maximum tolerated dose of GIC-102 in patients with advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma.
This study will comprise two phases.
GIC-102 is an "off-the-shelf" allogeneic natural killer cells isolated from non-HLA-related healthy donor. Natural killer cells are innate immune cells that show strong cytolytic function against physiologically stressed cells such as tumor cells and virus infected cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation phase: GIC-102 monotherapy | Experimental |
|
|
| Dose expansion phase: GIC-102 monotherapy | Experimental | - Dose level: RP2D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIC-102 | Drug | GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity assessment (dose escalation phase) | To determine the maximum tolerated dose of allogeneic natural killer cells | Up to 4 weeks |
| Adverse event / Immune related adverse event | To determine the safety of GIC-102 | through study completion, an average of 1 year |
| Objective Response Rate (ORR) (dose expansion phase) | To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma) | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) (dose escalation phase) | To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma) | through study completion, an average of 1 year |
| Progression free survival (PFS) |
| Measure | Description | Time Frame |
|---|---|---|
| PK Profile (dose escalation phase) -Cmax | up to 6 months | |
| PK Profile (dose escalation phase) - Tmax | up to 6 months | |
| PK Profile (dose escalation phase) - AUC |
Inclusion criteria:
Exclusion Criteria:
Clinically significant cardiovascular disease within 24 weeks
Primary malignant tumor other than the indications for this study
The following diseases
Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study
Received chemotherapy other than pre-conditioning within 4 weeks
Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks
Hypersensitivity reactions to the study drug or excipients
Hypersensitivity to cyclophosphamide or fludarabine
Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks
Have previously received an allogeneic tissue/solid organ transplant
Have administered other investigational drug or applied other investigational medical device within 4 weeks
Pregnant or lactating female subjects
Male subjects who did not agree to use contraception or to maintain abstinence
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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Dose escalation phase: up to 30 subjects / Dose expansion phase: up to 20 subjects
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| GIC-102 | Drug | GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle |
|
Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first |
| Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase) |
| Overall survival (OS) | Duration from start of study treatment to death (regardless of cause) | Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase) |
| Duration of response (DOR) | Time from the first occurrence of a documented objective response to the time of the first document disease progression or death from any cause | Through study completion |
| Disease Control Rate (DCR) | Percentage of patients who have achieved CR, PR and stable disease (SD) | through study completion, an average of 1 year |
| PK Profile (dose expansion phase) -Cmax | up to 6 months |
| PK Profile (dose expansion phase) - Tmax | up to 6 months |
| PK Profile (dose expansion phase) - AUC | up to 6 months |
| up to 6 months |
| Immune Profile |
| through study completion, an average of 1 year |
| Alloantibody Identification |
| through study completion, an average of 1 year |
| Seoul Asan Medical center | Recruiting | Seoul | South Korea |
|
| Seoul Asan Medical center | Not yet recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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