Actively Recruiting
Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC
Led by Beijing Biotech · Updated on 2026-03-30
30
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dual-Target GPC3/B7-H3 CAR-NK Cells for Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically or cytologically confirmed hepatocellular carcinoma or radiologically diagnosed HCC with tissue confirmation of GPC3 and B7-H3 expression
- Unresectable, locally advanced, or metastatic HCC not suitable for surgery, transplant, or locoregional therapy; BCLC stage C or stage B not suitable or progressed after locoregional therapy
- Disease progression on, intolerance to, or ineligibility for at least one prior standard systemic regimen
- Central pathology confirming GPC3 positivity in ≥25% of tumor cells and B7-H3 positivity in ≥10% of tumor or associated stromal/vascular cells
- At least one measurable lesion by RECIST 1.1 criteria; intrahepatic lesions assessable by contrast-enhanced triphasic CT or MRI
- ECOG performance status of 0 to 1
- Child-Pugh class A or stable class B7 without uncontrolled ascites or recent encephalopathy
- Estimated life expectancy of at least 12 weeks
- Adequate organ function including specified blood counts, liver enzymes, bilirubin, creatinine clearance, and coagulation parameters
- If positive for hepatitis B surface antigen or core antibody, controlled viral load with antiviral therapy before lymphodepletion; controlled hepatitis C virus allowed
- Negative pregnancy test for participants of childbearing potential and agreement to use effective contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior gene-modified cellular therapy within protocol-defined washout or unresolved significant toxicity
- Active uncontrolled infection including bacterial, viral, fungal infections, uncontrolled HIV, active hepatitis B or C with high viral load, or active tuberculosis
- Known active central nervous system metastases or leptomeningeal disease requiring escalating steroids or urgent intervention
- History of liver or other solid-organ transplant or current need for chronic immunosuppression
- Significant ascites requiring frequent drainage, grade ≥2 hepatic encephalopathy within 4 weeks, or recent serious variceal or gastrointestinal bleeding
- Extensive liver tumor replacement (≥70%) or major portal vein/hepatic vein obstruction posing excessive treatment risk
- Recent major surgery, locoregional therapy, radiotherapy, or systemic anticancer therapy within protocol-defined washout period
- Active autoimmune disease requiring systemic immunosuppressive therapy or chronic corticosteroids above protocol limits
- Significant cardiovascular disease, uncontrolled pulmonary disease, or other serious comorbidities increasing study risk
- Pregnant or breastfeeding
- Any other active malignancy that is progressing or requires systemic treatment
- Any medical or psychiatric condition that could compromise safety, protocol compliance, or result interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
Research Team
S
Seni S Lu, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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