Hepatocellular Carcinoma , Cholangiocarcinoma
Conditions
Brief summary
Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.
Interventions
BIOLOGICALanti-GPC3 CAR-T cells
A single arm, open-label pilot study is designed to determine the safety and efficacy of anti-GPC3 CAR-T cells in patients with GPC3-positive advanced liver cancer.
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* GPC3 expression was positive by histological examination; * 18-69 years old; * The patients with advanced liver tumor who can not be operated and the effect of chemotherapy is poor; * The patients who received traditional palliative therapy had an expected survival period of more than 4 months; * Organ status allows clinical application.a. Creatinine \< 1.5mg/dl; b. Cardiac ejection index \> 55%; c. Heme \> 9g / dl, bilirubin \< 2.0mg/dl; * No bleeding and coagulation disorders were found; * There was no allergy to contrast medium; * Contraception: contraceptive measures were taken during clinical application and within 3 months after the last cells transfusion; * There is no other contraindication for lymphocyte collection; * Sign informed consent.
Exclusion criteria
* Pregnant or lactating women; * Patients need systemic steroids therapy; * At present, the treatment conditions are as follows : a. Within 30 days before the collection of peripheral blood mononuclear cells,patiens were in other anti-tumor clinical observation period; b. Patients have not recovered from the acute side effects of previous treatment; * Patients received radiotherapy within 4 weeks after enrollment; * Patients received other cell modification therapy in the early stage; * In the screening stage, patients with lymphocyte transfection rate less than 5%, or T cell culture can not expand (\< 5 times) patients; * Uncontrolled symptoms or other diseases include, but are not limited to, infection, congestive heart failure, unstable angina pectoris, arrhythmia, psychosis, or limiting the social environment that meets the requirements, or the researchers believe that they may bring unpredictable risks; * Patients with severe acute allergic reactions; * Patients who participated in other clinical trials; * Researchers believe that patients are not suitable to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events attributed to the administration of the anti-GPC3 CAR-T cells | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | 2 years |
| Overall survival (OS) | 2 years |
Countries
China
Contacts
Primary ContactFei Wu
Outcome results
None listed