Clinical Trial Finder

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 3 months or more. 6. Acceptable hematological function, kidney, and liver function.

Exclusion Criteria:

1. Clinically significant cardiovascular disease within 6 months. 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

This is a first-in-human, open-label, non-randomized, dose-escalation phase 1 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. 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. Patients will receive at least 2 cycles of GIC-102 (each cycle is 3 treatments at a frequency of once a week, and 28 days is defined as one cycle). After treatment period, patients will undergo follow up for survival every 8 weeks for up to 6 months.

Arms

Experimental: GIC-102

On day -5, -4, and -3, patients receive cyclophosphamide 300 mg/m² and fludarabine 30mg/m² every 2 cycles On day 0, patients receive GIC-102 3 times at intervals of 1 week, and 28 days is defined as 1 cycle

Interventions

Biological: - GIC-102 (Allogeneic NK cells)

Dose level 1: 1 x 10^9 cells Dose level 2: 3 x 10^9 cells Dose level 3: 1 x 10^10 cells