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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorShenzhen University General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

40~70 years old;

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;

Patients who have been terminated for more than 28 days due to previous ineffective PD-1 monoclonal antibody treatment;

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;

Disqualifiers

Pregnant or lactating women;

HCV-RNA, HIV antibody or syphilis antibody are positive;

Any uncontrollable active infection, including but not limited to active tuberculosis;

Have received systemic steroids equivalent to>15 mg prednisone within 2 weeks before single collection, except inhaled steroids;

Trial design

Design model

Single group

Treatments tested in this trial

  • GPC3 CAR-T cells

    Biological/Vaccine

    patients treated with GPC3 CAR-T cells

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AE/SAE

adverse event/sever adverse event

Time frame
from cell infusion to 30 days after infusion

Secondary outcomes

1

ORR

overall response rate

Time frame
From admission to the end of follow up, up to 2 years.

Other outcomes

Sponsors and contacts

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