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

Early Phase 1

• Conditions: Hepatocellular Carcinoma , Cholangiocarcinoma
• Interventions: Biological: anti-GPC3 CAR-T cells

• Registration Number: NCT04951141
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-24
• Study First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-01
• Study First Posted: 2021-07-06
• Last Update Posted: 2021-07-06
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-GPC3 CAR-T	anti-GPC3 CAR-T cells	-

Primary Outcome Measures

Name	Time	Method
Adverse events attributed to the administration of the anti-GPC3 CAR-T cells	2 years

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	2 years
Objective response rate (ORR)	2 years

Trial Locations

Locations (1)

The Fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, China