GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma

Phase 1TerminatedNCT05352542

jianming xu10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Hepatocellular Carcinoma

Interventions

GPC3 Targeting CART CellsBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (2)

Beijing Gobroad Boren Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Incidence, severity, and type of treatment-emergent adverse events (TEAEs)

An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment