GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

jianming xu

Status and phase: Terminated; Phase 1

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Biological: GPC3 Targeting CART Cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05352542

GPC3-targeting Study

Details and patient eligibility

About

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

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

GPC3 Targeting CART Cells

Experimental group

Description:

Each subject will receive GPC3 Targeting CART cells

Treatment:

Biological: GPC3 Targeting CART Cells