A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai GeneChem Co., Ltd.
• Collaborator: Shanghai Cancer Hospital, China

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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