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 monotherapy dose escalation Phase * GIC-102 monotherapy dose expansion phase 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Korea University Anam Hospital
Seoul, South Korea
RECRUITINGSeoul Asan Medical center
Seoul, South Korea
RECRUITINGSeoul Asan Medical center
Seoul, South Korea
NOT_YET_RECRUITINGDose-limiting toxicity assessment (dose escalation phase)
To determine the maximum tolerated dose of allogeneic natural killer cells
Time frame: Up to 4 weeks
Adverse event / Immune related adverse event
To determine the safety of GIC-102
Time frame: 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)
Time frame: through study completion, an average of 1 year
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)
Time frame: through study completion, an average of 1 year
Progression free survival (PFS)
Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first
Time frame: 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)
Time frame: 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
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Seoul National University Hospital
Seoul, South Korea
RECRUITINGTime frame: Through study completion
Disease Control Rate (DCR)
Percentage of patients who have achieved CR, PR and stable disease (SD)
Time frame: through study completion, an average of 1 year
PK Profile (dose expansion phase) -Cmax
Time frame: up to 6 months
PK Profile (dose expansion phase) - Tmax
Time frame: up to 6 months
PK Profile (dose expansion phase) - AUC
Time frame: up to 6 months