GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

NCT ID: NCT05352542

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2024-07-31

Brief Summary

A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

Detailed Description

This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of CART cell in patients ≥ 18 years of age with relapsed or refractory advanced hepatocellular carcinoma. Patients who meet the eligibility criteria will receive cell infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GPC3 Targeting CART Cells

Each subject will receive GPC3 Targeting CART cells

Group Type: EXPERIMENTAL

GPC3 Targeting CART Cells

Intervention Type: BIOLOGICAL

before treatment with GPC3 Targeting CART cells, subjects will receive a conditioning regimen

Interventions

GPC3 Targeting CART Cells

before treatment with GPC3 Targeting CART cells, subjects will receive a conditioning regimen

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;

2. Age 18-75 years;

3. Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;

4. GPC3 is detected positive by immunohistochemistry (IHC);

5. Child-Pugh score ≤ 7;

6. At least one assessable tumor lesion;

7. ECOG score: 0-1;

8. Expected survival ≥ 3 months;

9. Clinical laboratory values meet screening visit criteria

Exclusion Criteria

1. Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;

2. Any previous GPC3 targeted therapy;

3. Prior antitumor therapy with insufficient washout period;

4. Brain metastases with central nervous system symptoms;

5. Pregnant or lactating women

6. HCV-Ab or/and HIV-Ab positive; active syphilis;

7. Severe underlying diseases

8. Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

jianming xu

OTHER

Sponsor Role: lead

Responsible Party

jianming xu

Leading Site Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

GPC3-targeting Study

Identifier Type: -

Identifier Source: org_study_id