GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R/R Hematologic Malignancies

Exclusion Criteria18

• 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