Overview
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.
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.
Eligibility
Inclusion criteria:
- At least 19 years of age
- Advanced solid tumors, relapsed/refractory non-hodgkin lymphoma, and multiple myeloma
- At least one measurable or evaluable lesion
- Eastern Cooperative Oncology Group performance status 0 or 1
- A life expectancy of 12 weeks or more
- Acceptable hematological function, kidney, and liver function
- Subjects who sign on an informed consent form willingly
Exclusion Criteria:
- Clinically significant cardiovascular disease within 24 weeks
- Primary malignant tumor other than the indications for this study
- The following diseases
- Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks
- The New York Heart Association class III/IV
- Active hepatitis B virus or hepatitis C virus infection
- Human immunodeficiency virus positive
- Clinically significant symptoms or uncontrolled central nervous system metastasis
- 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
