Clinical Efficacy and Safety of NKT Cell Infusion in Patients With Advanced Solid Tumor

This is an interventional treatment trial for Non-small Cell Lung Cancer Read More

Inclusion Criteria:

• Age: 18 to 75 years, Male or Female
• Histological or cytologically diagnosis of advanced non-small cell lung cancer, or advanced gastric cancer, or advanced hepatocellular carcinoma, or advanced colorectal cancer
• Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
• Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧11.0 g/dL, Neutrophils count≧1.5×l09/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧80×l09/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
• No dyspnea at rest. Oxygen saturation ≥90% on room air
• Able to tolerate apheresis procedure including placement of temporary apheresis catheter
• No genetic disease
• No chemotherapy and radiation therapy to be planned recently
• Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
• Patients must have a Karnofsky performance status greater than or equal to 80%
• Life expectancy greater than twelve months
• Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
• Agree that progress of the disease must be radiographically measurable by computerized tomography (CT) scanning technique or magnetic resonance imaging (MRI) (per RECIST1.1 criteria)
• Agrees to participate in long-term follow-up for up to 3 years, if received NKT infusion

Exclusion Criteria:

• Organ dysfunction defined as follows: Significant cardiovascular disease (i.e. New York Heart Association [NYHA] class 3 congestive heart failure, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness
• Suffering from lymphoma or leukemia
• Serious infections requiring antibiotics, bleeding disorders
• Patients with myelodysplastic syndrome (MDS)
• History of immunodeficiency disease or autoimmune disease
• Known or suspected allergy to the investigational agent or any agent given in association with this trial
• Known central nervous system tumors including metastatic brain disease, unless treated and stable
• Other malignancy within 3 years prior to entry into the study
• Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
• Patients with chronic disease which is undergoing immune reagents or hormone therapy
• Previous bone marrow or stem cell transplant, or organ allograft
• Within concurrent chemotherapy
• Concomitant treatment with corticosteroids (Topical or inhalational corticosteroids are permitted)
• Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
• Pregnant or breast-feeding patients
• Mental impairment or addictive disorders that may compromise the ability to give informed consent
• Lack of availability of a patient for immunological and clinical follow-up assessment