A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
NCT ID: NCT02959151
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2016-07-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T for liver cancer
A single dose of CART cells will be administered by vascular interventional therapy or by intra-tumor injection with a 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. And an interventional radiologist would operate the cell infusion.
CAR-T cell
CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.
Interventions
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CAR-T cell
CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
69 Years
ALL
No
Sponsors
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Shanghai Cancer Hospital, China
OTHER
Shanghai GeneChem Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wentao Li, doctor
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wentao Li, doctor
Role: primary
Xuejun Yu, master
Role: backup
Other Identifiers
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CAR-T for liver cancer
Identifier Type: -
Identifier Source: org_study_id