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

Last updated: July 1, 2021
Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Liver Cancer

Digestive System Neoplasms

Abdominal Cancer

Treatment

N/A

Clinical Study ID

NCT04951141
2017-003-D
  • Ages 18-69
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 ofchemotherapy is poor;
  • The patients who received traditional palliative therapy had an expected survivalperiod of more than 4 months;
  • Organ status allows clinical application.a. Creatinine < 1.5mg/dl; b. Cardiac ejectionindex > 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 andwithin 3 months after the last cells transfusion;
  • There is no other contraindication for lymphocyte collection;
  • Sign informed consent.

Exclusion

Exclusion Criteria:

  • Pregnant or lactating women;
  • Patients need systemic steroids therapy;
  • At present, the treatment conditions are as follows : a. Within 30 days before thecollection of peripheral blood mononuclear cells,patiens were in other anti-tumorclinical observation period; b. Patients have not recovered from the acute sideeffects 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 Tcell 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 limitingthe social environment that meets the requirements, or the researchers believe thatthey 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 Design

Total Participants: 10
Study Start date:
January 01, 2019
Estimated Completion Date:
December 21, 2023

Connect with a study center

  • The Fifth Medical Center of Chinese PLA General Hospital

    Beijing, 100039
    China

    Active - Recruiting

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