A Study Of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy In Advanced Liver Malignancy

Study Overview

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

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.

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.

Carcinoma, Hepatocellular
Pancreatic Cancer Metastatic
Colorectal Cancer Metastatic

DRUG: CAR-T cell

CAR-T for liver cancer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2016-11-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2016-11-07
First Submitted that Met QC Criteria 2016-11-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2016-11-08
First Posted (ESTIMATED) 2016-11-08	Results First Posted N/A	Last Verified 2016-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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 woul	DRUG: 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 ca

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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 woul

DRUG: 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 ca

Primary Outcome Measures	Measure Description	Time Frame
Number of patients with adverse event	adverse event is evaluated with CTCAE, version 4.0	6 weeks

Secondary Outcome Measures	Measure Description	Time Frame
Number of patients with tumor response	summarize tumor response by overall response rates	8 weeks
Detection of transferred T cells in the circulation using quantitative -PCR		8 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Wentao Li, doctor

Phone Number: +86 18017312650

Email: liwentao98@126.com

Study Contact Backup

Name: Xuejun Yu, master

Phone Number: +86 18616108610

Email: yuxuejun@genechem.com.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Shanghai Cancer Hospital, China

Investigators

PRINCIPAL_INVESTIGATOR: Wentao Li, doctor, Fudan University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record