Safety Study of Adoptive Transfer of Autologous IKDC-like Cells

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Cancer immunotherapy, IFN-γ-producing killer dendritic cell-like cells, Natural killer cells Read More

Inclusion Criteria:

• Histologically confirmed metastatic/recurrent non-hematological cancer, stage IV at study entry.
• Age: 21-75 years.
• ECOG performance status 0-1.
• Patients must have at least one measurable lesion.
• Patients' disease must have failed at least one-line of standard chemotherapy/targeted therapy or other treatment in the metastatic setting.
• Patients' estimated life expectancy is more than 3 months.
• Patients who refuse chemotherapy, or who are physiologically unsuitable for chemotherapy or any other standard therapy per investigator's discretion will be considered eligible for this trial.
• Patients must have adequate bone marrow function, defined as WBC ≥ 3500/mm3, neutrophil ≥ 1500/mm3, lymphocyte ≥ 1,000/mm3, and platelet ≥ 100,000/mm3.
• Patients must have adequate liver and renal function, defined as serum alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 times normal, bilirubin ≤ 1.5 times normal range, and creatinine ≤ 1.5 times upper normal limit.
• All patients should have documentation of negative result of penicillin test.
• Women or men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion Criteria:

• Subjects with metastatic cancer in disease progression (expected survival time < 3 months).
• Subjects who have had chemotherapy less than 4 weeks before the start of trial.
• Subjects who received IFN-γ or GM-CSF less than 4 weeks before the start of trial.
• Subjects who are HIV, HBV, or HCV positive.
• Patients who have central nervous system metastasis except for those whose CNS disease have been treated with radiotherapy (Disease-free > 6 months) and/or surgery and have been stable for at least two weeks.
• Patients who have active acute or chronic infection (at the discretion of the investigator).
• Pregnant or breast-nursing women.
• Patients who have active cardiac disease requiring therapy for failure, angina, arrhythmia, or infarction within the preceding 6 months (exception: any patient whose cardiac failure is compensated on medications).
• Subjects who have received corticosteroids or other immunosuppressive agents less than 4 weeks before starting trial.
• Subjects who have asthma and/or are on treatment for asthma.
• Subjects with history of autoimmune disease, such as lupus, multiple sclerosis, Ankylosing Spondylitis, Systemic Sclerosis.
• Subjects with a history of other systemic disease..
• History of neoplastic disease within the last 5 years except for carcinoma in situ of the cervix, superficial bladder cancer or basal/squamous cell carcinoma of the skin.
• Subjects who present with open wounds.