Advanced Solid Tumors, Relapsed/Refractory Multiple Myeloma, Relapsed/Refractory Non-Hodgkin Lymphoma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGGIC-102
GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle
Sponsors
GI Cell, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation phase: up to 30 subjects / Dose expansion phase: up to 20 subjects
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 19 years of age 2. Advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma 3. At least one measurable or evaluable lesion 4. Eastern Cooperative Oncology Group performance status 0 or 1 5. A life expectancy of 12 weeks or more 6. Acceptable hematological function, kidney, and liver function 7. Subjects who sign on an informed consent form willingly
Exclusion criteria
1. Clinically significant cardiovascular disease within 24 weeks 2. Primary malignant tumor other than the indications for this study 3. The following diseases 1. Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks 2. The New York Heart Association class III/IV 3. Active hepatitis B virus or hepatitis C virus infection 4. Human immunodeficiency virus positive 5. Clinically significant symptoms or uncontrolled central nervous system metastasis 4. 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 5. Received chemotherapy other than pre-conditioning within 4 weeks 6. Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks 7. Hypersensitivity reactions to the study drug or excipients 8. Hypersensitivity to cyclophosphamide or fludarabine 9. Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks 10. Have previously received an allogeneic tissue/solid organ transplant 11. Have administered other investigational drug or applied other investigational medical device within 4 weeks 12. Pregnant or lactating female subjects 13. Male subjects who did not agree to use contraception or to maintain abstinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity assessment (dose escalation phase) | Up to 4 weeks | To determine the maximum tolerated dose of allogeneic natural killer cells |
| Objective Response Rate (ORR) (dose expansion phase) | through study completion, an average of 1 year | To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma) |
| Adverse event / Immune related adverse event | through study completion, an average of 1 year | To determine the safety of GIC-102 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | Through study completion | Time from the first occurrence of a documented objective response to the time of the first document disease progression or death from any cause |
| Overall survival (OS) | Through study completion / 6-month, 12-month, 18-month, overall timepoint(dose expansion phase) | Duration from start of study treatment to death (regardless of cause) |
| Disease Control Rate (DCR) | through study completion, an average of 1 year | Percentage of patients who have achieved CR, PR and stable disease (SD) |
| 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 | — |
| Objective response rate (ORR) (dose escalation phase) | through study completion, an average of 1 year | To evaluate the efficacy of GIC-102 according to RECISTv1.1(solid tumor), Lugano 2014 (non-Hodgkin's lymphoma), IMWG 2016 (multiple myeloma) |
| Progression free survival (PFS) | Through study completion / 6-month, 12-month, 18-month (solid tumor, dose expansion phase) | Duration from start of study treatment to progression diease or death (regardless of cause), whichever comes first |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alloantibody Identification | through study completion, an average of 1 year | * donor human leukocyte antigen (HLA) class I-specific antibody (positive/negative) * donor HLA class II-specific antibody (positive/negative) |
| PK Profile (dose escalation phase) - Tmax | up to 6 months | — |
| Immune Profile | through study completion, an average of 1 year | * Immune response activation factor (Immune subset marker, cytokine expression) * Immunophenotyping of peripheral blood mononuclear cells will be performed by flow cytometry |
| PK Profile (dose escalation phase) - AUC | up to 6 months | — |
| PK Profile (dose escalation phase) -Cmax | up to 6 months | — |
Countries
South Korea
Outcome results
None listed