Clinical Study of Intratumoral Injection of CAR-T Cells in the Treatment of Advanced Liver Tumors
NCT ID: NCT04951141
Last Updated: 2021-07-06
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
EARLY_PHASE1
10 participants
INTERVENTIONAL
2019-01-01
2023-12-21
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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anti-GPC3 CAR-T
anti-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.
Interventions
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anti-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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
69 Years
ALL
No
Sponsors
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Beijing Immunochina Medical Science & Technology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yin ying Lu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijing 302 Hospital
Locations
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The Fifth Medical Center of Chinese PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-003-D
Identifier Type: -
Identifier Source: org_study_id
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