A Study of GIC-102 (Allogeneic Natural Killer Cells) in Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, and Multiple Myeloma
Advanced Solid Tumors, Relapsed/Refractory Non-Hodgkin Lymphoma, Relapsed/Refractory Multiple Myeloma
About this trial
This is an interventional treatment trial for Advanced Solid Tumors
Eligibility Criteria
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 3 months or more Acceptable hematological function, kidney, and liver function Exclusion Criteria: Clinically significant cardiovascular disease within 6 months 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
Sites / Locations
- Korea University Anam HospitalRecruiting
- Seoul Asan Medical centerRecruiting
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
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