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OncoMatch/Clinical Trials/NCT07500220

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

Is NCT07500220 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including EB-G3B7-NK dual-target CAR-NK cells and Fludarabine for advanced hepatocellular carcinoma (hcc).

Phase 1/2RecruitingBeijing BiotechNCT07500220Data as of May 2026

Treatment: EB-G3B7-NK dual-target CAR-NK cells · Fludarabine · Cyclophosphamideopen-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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Biomarker criteria

Required: GPC3 positivity in >=25% of viable tumor cells by IHC (>=25% of viable tumor cells by IHC)

Central pathology showing GPC3 positivity in >=25% of viable tumor cells by IHC

Required: B7H3 positivity in >=10% of tumor cells and/or tumor-associated stromal/vascular cells by IHC (>=10% of tumor cells and/or tumor-associated stromal/vascular cells by IHC)

B7-H3 positivity in >=10% of tumor cells and/or tumor-associated stromal/vascular cells by IHC

Disease stage

Required: Stage BCLC STAGE C, STAGE B NOT SUITABLE FOR OR HAS PROGRESSED AFTER LOCOREGIONAL THERAPY (BCLC)

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

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard systemic regimen

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

Cannot have received: gene-modified cellular therapy (CAR-T, CAR-NK, TCR-engineered therapy)

Exception: allowed if outside protocol-defined washout period and no unresolved clinically significant toxicity

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

Lab requirements

Blood counts

WBC >=2.5 x 10^9/L; platelets >=60 x 10^9/L; hemoglobin >=9 g/dL

Kidney function

creatinine clearance >=40 mL/min

Liver function

Child-Pugh class A or stable Child-Pugh B7 without uncontrolled ascites or recent encephalopathy; AST/ALT <=5 x ULN; total bilirubin <=2.5 x ULN; serum albumin >=30 g/L; INR/prothrombin time within protocol-defined range

Adequate organ function: WBC >=2.5 x 10^9/L; platelets >=60 x 10^9/L; hemoglobin >=9 g/dL; serum albumin >=30 g/L; creatinine clearance >=40 mL/min; AST/ALT <=5 x ULN; total bilirubin <=2.5 x ULN; INR/prothrombin time within protocol-defined range

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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