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Safety and Efficacy of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients With Unresectable Recurrent/Metastatic Hepatocellular Carcinoma

ConditionHepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age19-75
SponsorZhejiang University

About this trial

A Study of Metabolically Armed GPC3 CAR-T Cells Injection (Meta10-GPC3) in Patients with Unresectable Recurrent/Metastatic Hepatocellular Carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years and ≤75 years, male or female.

Histologically confirmed recurrent or metastatic hepatocellular carcinoma (HCC) that is not amenable to surgical resection.

At least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Tumor tissue must test positive for GPC3 expression by immunohistochemical (IHC), defined as > 25% of tumor cells staining for GPC3 in the pathological specimen. Preferably, the target lesion sample should be used, including freshly obtained tumor tissue or archival tissue samples deemed acceptable by the investigator.

Disqualifiers

Pregnant or breastfeeding women, or women of childbearing potential who test positive on a pregnancy test during the screening period).

Active hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection; seropositivity for Human Immunodeficiency (HIV) or syphilis.

Any uncontrolled active infection, including but not limited to active pulmonary tuberculosis.

Therapeutic doses of corticosteroids must be discontinued at least 2 weeks prior to Meta10-GPC3 infusion; any immunosuppressive medications must be discontinued at least 4 weeks before signing the informed consent form.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Metabolically Armed GPC3 CAR-T cells

    Drug

    Each subject receive metabolically armed GPC3 CAR- T cells by intravenous infusion.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Administration of Metabolically Armed GPC3 CAR-T TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

To characterize the safety profile of Meta10-GPC3 in patients with unresectable recurrent/metastatic hepatocellular carcinoma as assessed by incidence of adverse events. Adverse events will be graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Time frame
Within 2 years post Meta10-GPC3 infusion.

Secondary outcomes

1

Objective response rate (ORR)

To evaluate the proportion of participants who have a confirmed partial response (PR) and complete response (CR) per RECIST v1.1 as assessed by the investigator.

Time frame
12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
2

Duration of Response (DOR)

To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to any cause.

Time frame
12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
3

Progression-free survival (PFS)

The time from the start of Meta10-GPC3 treatment for the subjects to the first disease progression or death for any reason.

Time frame
12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion.
4

Overall survival (OS)

OS is measured from the date of the infusion of Meta10-GPC3 to the date of the subjects' death.

Time frame
12 week, 20 week, 28 week, 40 week, 52 week, 78 week, 104 week post Meta10-GPC3 infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Leman Biotech Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: