Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor

Launched by SHANGHAI PUBLIC HEALTH CLINICAL CENTER · Mar 22, 2017

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment for people with advanced cancers such as lung, pancreatic, liver, stomach, and kidney cancers. The treatment involves giving patients special immune cells called iNKT cells and CD8+ T cells, which are designed to help the body’s own defense system fight the cancer more effectively. The main goal of the study is to see if this treatment is safe and if it can help reduce the size of tumors or improve how long patients live.

People who might be eligible to join this trial are adults with advanced stages of certain solid tumors who meet specific health requirements, like having good blood counts and enough healthy organ function. Participants must be able to give informed consent and agree to follow-up visits for up to a year. During the study, patients will receive infusions of these immune cells and be closely monitored to check for side effects and any benefits. It’s important to note that people with serious heart, kidney, or immune system problems, or those currently undergoing other cancer treatments, may not be able to participate. This study is currently recruiting patients who want to explore this new immune-based therapy option.

Gender

ALL

Eligibility criteria

• 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