OncoMatch/Clinical Trials/NCT07500220
Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC
Is NCT07500220 recruiting? Yes, currently enrolling (Jun 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).
Treatment: EB-G3B7-NK dual-target CAR-NK cells · Fludarabine · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
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)
Demographics
Prior therapy
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.
Frequently asked questions
Is NCT07500220 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior gene-modified cellular therapy disqualifies patients from enrollment.
Does this trial require GPC3?
Yes, GPC3 positivity in >=25% of viable tumor cells by IHC is a required biomarker for enrollment.
Does this trial require B7H3?
Yes, B7H3 positivity in >=10% of tumor cells and/or tumor-associated stromal/vascular cells by IHC is a required biomarker for enrollment.
What disease stage is eligible?
Stage BCLC STAGE C or STAGE B NOT SUITABLE FOR OR HAS PROGRESSED AFTER LOCOREGIONAL THERAPY is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages