Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CAR-T for liver cancer
- NCT ID:
NCT02959151
Conditions
- Carcinoma, Hepatocellular
- Pancreatic Cancer Metastatic
- Colorectal Cancer Metastatic
Interventions
| Drug | Synonyms | Arms |
|---|
| CAR-T cell | chimeric antigen receptor T cells | CAR-T for liver cancer |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| CAR-T for liver cancer | Experimental | 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. | |
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
| Maximum Eligible Age: | 69 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of patients with adverse event |
| Time Frame: | 6 weeks |
| Safety Issue: | |
| Description: | adverse event is evaluated with CTCAE, version 4.0 |
Secondary Outcome Measures
| Measure: | Number of patients with tumor response |
| Time Frame: | 8 weeks |
| Safety Issue: | |
| Description: | summarize tumor response by overall response rates |
| Measure: | Detection of transferred T cells in the circulation using quantitative -PCR |
| Time Frame: | 8 weeks |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Shanghai GeneChem Co., Ltd. |
Last Updated
November 8, 2016
