Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor
Recruiting · NCT03093688 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai Public Health Clinical Center
View the official record on ClinicalTrials.gov →Interventions studied
Infusion of iNKT cells and CD8+T cells
What this trial is about
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or 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≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/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
- No genetic disease
- 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%
- Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
- Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion
Exclusion criteria
- Organ dysfunction,such as significant cardiovascular disease, 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; Renal failure.
- Suffering from lymphoma or leukemia
- Serious infections requiring antibiotics, bleeding disorders
- Patients with myelodysplastic syndrome (MDS)
- History of immunodeficiency disease or autoimmune disease
- Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
- Within concurrent chemotherapy
- 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
- Can't give informed consent
- Lack of availability for follow-up assessment
Where it is running
1 location listed.
- Shanghai Public Health Clinical Center - Shanghai, Shanghai Municipality, China