Designer T cells are prepared by PBMC which from patients or suitable donator by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs). There are three options for CAR-targets: GPC3 for hepatocellular carcinoma; mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic. Cells are expanded in culture and returned to the participant by vascular interventional therapy or by intra-tumor injection at the dose of (1.25\~4)×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused.
Age
18–69
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
tumor histological examination confirmed as GPC3/ mesothelin/CEA positive expression;
persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients
life expectancy greater than 6 months
satisfactory organ and bone marrow function as defined by the following: (1) creatinine \<1.5mg/dl; (2) cardiac ejection fraction of \>55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit
without bleeding disorder or coagulation disorders
Don't allergy to Radiocontrast agent
birth control
Adequate venous access for apheresis, and no other contraindications for leukapheresis
Voluntary informed consent is given
You may not be if
Pregnant or lactating women
Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before
Four weeks before recruit accepted radiation therapy
Previously treatment with any gene therapy products
Feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to CD3/CD28 costimulation
Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases)
Patient with severe acute hypersensitive reaction
Taking part in other clinical trials
Study leader considers not suitable for this tiral
Clareo Health | A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy