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

July 1, 2021 updated by: Beijing Immunochina Medical Science & Technology Co., Ltd.

Beijing Immunochina Medical Science & Technology Co., Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center of Chinese PLA General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events attributed to the administration of the anti-GPC3 CAR-T cells
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 2 years
2 years
Objective response rate (ORR)
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Immunochina Medical Science & Technology Co., Ltd.

Investigators

  • Principal Investigator: Yin ying Lu, M.D., Beijing 302 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ANTICIPATED)

September 30, 2023

Study Completion (ANTICIPATED)

December 21, 2023

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (ACTUAL)

July 6, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-003-D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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