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Clinical Study of Intratumoral Injection of CAR-T Cells in the Treatment of Advanced Liver Tumors

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ClinicalTrials.gov Identifier: NCT04951141
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : July 6, 2021
Sponsor:
Information provided by (Responsible Party):
Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary:
Objective to study the safety and preliminary efficacy of intratumoral injection of CAR-T cells in the treatment of advanced liver tumors.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma , Cholangiocarcinoma Biological: anti-GPC3 CAR-T cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Beijing Immunochina Medical Science & Technology Co., Ltd.
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: anti-GPC3 CAR-T Biological: 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.




Primary Outcome Measures :
  1. Adverse events attributed to the administration of the anti-GPC3 CAR-T cells [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 2 years ]
  2. Overall survival (OS) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951141


Contacts
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Contact: Fei Wu +8615801390058 wufei@immunochina.com

Locations
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China
The Fifth Medical Center of Chinese PLA General Hospital Recruiting
Beijing, China, 100039
Contact: Yin ying Lu, M.D.       luyinying1973@163.com   
Sponsors and Collaborators
Beijing Immunochina Medical Science & Technology Co., Ltd.
Investigators
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Principal Investigator: Yin ying Lu, M.D. Beijing 302 Hospital
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Responsible Party: Beijing Immunochina Medical Science & Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT04951141    
Other Study ID Numbers: 2017-003-D
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases