Health TrialsbyHealthPanel

Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC

ConditionsAdvanced Hepatocellular Carcinoma (HCC)Metastatic Liver Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Biotech

About this trial

open-label trial of an allogeneic dual-target CAR-NK product directed against GPC3 and B7-H3 for adults with advanced hepatocellular carcinoma. The design intentionally uses GPC3 as the primary target anchor because GPC3 is the dominant HCC cell-therapy antigen in current clinical development, while adding B7-H3 to reduce antigen escape and to broaden coverage across tumor and tumor-microenvironment compartments. The study first evaluates safety and dose-limiting toxicities, then expands at the recommended phase 2 dose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 75 years.

Histologically or cytologically confirmed HCC, or radiologically diagnosed HCC with mandatory tissue confirmation of target expression before enrollment.

Unresectable, locally advanced, or metastatic HCC not amenable to curative surgery, transplant, or further locoregional therapy; BCLC stage C, or stage B that is not suitable for or has progressed after locoregional therapy.

Disease progression on, intolerance to, or ineligibility for at least 1 prior standard systemic regimen.

Disqualifiers

Prior gene-modified cellular therapy (for example prior CAR-T, CAR-NK, or TCR-engineered therapy) within the protocol-defined washout period or with unresolved clinically significant toxicity.

Active, uncontrolled infection, including uncontrolled bacterial, viral, or fungal infection; uncontrolled HIV; active HBV or HCV with uncontrolled viral load; or active tuberculosis.

Known active CNS metastases or leptomeningeal disease requiring escalating steroids or urgent local intervention.

Liver transplant or other solid-organ transplant history, or current requirement for chronic immunosuppression.

Trial design

Design model

Sequential

Treatments tested in this trial

  • EB-G3B7-NK dual-target CAR-NK cells

    Biological/Vaccine

    Allogeneic donor-derived NK cells genetically modified to express a dual-target CAR recognizing GPC3 and B7-H3/CD276. Administered intravenously after lymphodepletion.

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy given before CAR-NK infusion.

  • Cyclophosphamide

    Drug

    Lymphodepleting chemotherapy given before CAR-NK infusion.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: EB-G3B7-NK dual-target CAR-NK cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicities (DLTs)

Time frame
28 Days
2

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

Time frame
12 months

Secondary outcomes

1

response rate (ORR) by RECIST 1.1 and mRECIST

Time frame
6 months
2

Disease control rate (DCR)

Time frame
6 months
3

Duration of response (DoR)

Time frame
12 months
4

Progression-free survival (PFS)

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Beijing Biotech

Lead sponsor

Source ClinicalTrials.gov
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