Back to resultsA Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
Primary Purpose
Carcinoma, Hepatocellular, Pancreatic Cancer Metastatic, Colorectal Cancer Metastatic
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T cell
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular
Eligibility 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
Sites / Locations
- Shanghai Tumor HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T for liver cancer
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of patients with adverse event
adverse event is evaluated with CTCAE, version 4.0
Secondary Outcome Measures
Number of patients with tumor response
summarize tumor response by overall response rates
Detection of transferred T cells in the circulation using quantitative -PCR
Full Information
NCT ID
NCT02959151
First Posted
November 6, 2016
Last Updated
November 7, 2016
Sponsor
Shanghai GeneChem Co., Ltd.
Collaborators
Shanghai Cancer Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02959151
Brief Title
A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
Official Title
A Single-arm Pilot Clinical Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai GeneChem Co., Ltd.
Collaborators
Shanghai Cancer Hospital, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular, Pancreatic Cancer Metastatic, Colorectal Cancer Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T for liver cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CAR-T cell
Other Intervention Name(s)
chimeric antigen receptor T cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with adverse event
Description
adverse event is evaluated with CTCAE, version 4.0
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Number of patients with tumor response
Description
summarize tumor response by overall response rates
Time Frame
8 weeks
Title
Detection of transferred T cells in the circulation using quantitative -PCR
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wentao Li, doctor
Phone
+86 18017312650
Email
liwentao98@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xuejun Yu, master
Phone
+86 18616108610
Email
yuxuejun@genechem.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wentao Li, doctor
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Tumor Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201206
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wentao Li, doctor
Phone
+ 86 18017312650
Email
liwentao98@126.com
First Name & Middle Initial & Last Name & Degree
Xuejun Yu, master
Phone
+86 18616108610
Email
yuxuejun@genechem.com.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
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