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Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma | Clinical Trials | Clareo Health

RECRUITINGNA

Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma

Study of GPC-3 CAR-T Cells in Advanced Hepatocellular Carcinoma

NCT05620706•Shenzhen University General Hospital

Summary

Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. It is highly expressed in liver cancer tissues, but hardly expressed in normal liver tissues. It is an ideal target for tumor treatment. Investigators aimed to test the safety and efficacy of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.

Detailed Description

Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Resulting in a poor prognosis. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. It is highly expressed in liver cancer tissues, but hardly expressed in normal liver tissues. It is an ideal target for tumor treatment. Investigators aimed to test the safety and efficacy of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 40\~70 years old;
•2. Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, who are not suitable for surgery or local treatment (including ablation therapy, interventional therapy and radiotherapy), and who have experienced progress or intolerance after receiving standard treatment in the past;
•3. Patients who have been terminated for more than 28 days due to previous ineffective PD-1 monoclonal antibody treatment;
•4. At least one target lesion that can be evaluated stably according to RECIST 1.1 standard is defined as: the longest diameter of non lymph node lesions ≥ 10mm, or the short diameter of lymph node lesions ≥ 15mm; Intrahepatic lesions require enhanced imaging in arterial phase;
•5. Tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC);
•6. Grade C according to Barcelona liver cancer grading standard (BCLC) or Grade B which is not suitable for local treatment/progression of local treatment;
•7. Estimated survival time \> 12 weeks;
•8. Cirrhotic state Child Pugh score Grade A
•9. ECOG physical status score 0\~1;
•10. If the patient is HBsAg positive or HBcAb positive, HBV-DNA\<200IU/ml. HBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015);
+11 more criteria

Exclusion Criteria

•1. Pregnant or lactating women;
•2. HCV-RNA, HIV antibody or syphilis antibody are positive;
•3. Any uncontrollable active infection, including but not limited to active tuberculosis;
•4. Have received systemic steroids equivalent to\>15 mg prednisone within 2 weeks before single collection, except inhaled steroids;
•5. Allergies to immunotherapy and related drugs, previous severe allergies β- Allergy to lactam antibiotics;
•6. Previous or current hepatic encephalopathy;
•7. At present, there is ascites with clinical significance, which is defined as: ascites with positive signs on physical examination or ascites that need to be controlled by intervention (such as puncture or drug therapy) (only those with ascites shown on imaging without intervention can be included);
•8. Imaging examination results: the proportion of liver being replaced by tumor ≥ 50%, or portal trunk tumor thrombus, or tumor thrombus invading mesenteric vein/inferior vena cava;
•9. Central nervous system metastasis and diseases of central nervous system with clinical significance;
•10. At present, there is a heart disease that needs treatment or hypertension that is judged by the researcher to be poorly controlled (systolic blood pressure\>160mmHg or diastolic blood pressure\>100mmHg);
+8 more criteria

Locations (1)

Li Yu

Shenzhen, Guangdong, China

Key Dates

Start Date

November 1, 2022

Primary Completion Date

October 31, 2025

Completion Date

October 31, 2028

Last Updated

November 22, 2022

Enrollment

ESTIMATED participants

Conditions

Advanced Hepatocellular Carcinoma

Interventions

GPC3 CAR-T cells

BIOLOGICAL

Contacts

Li Yu, Dr

CONTACT

+8675521839178 liyu@vip.163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma

Inclusion Criteria

Exclusion Criteria

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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