Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
Study Details
Study Description
Brief Summary
This study was a single-center, open-label, investigator-initiated clinical trial (IIT) to observe and investigate the clinical safety and efficacy of SZ003 in the treatment of advanced hepatocellular carcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SZ003 CAR-NK
|
Biological: SZ003 CAR-NK
Drug: SZ003 CAR-NK In the escalation study, the minimum initial dose was 5.0×10^6 cells, then increased to 1.0×10^8 ,2.0×10^8 and5.0×10^8 cells. The infusion is given every 2 weeks.
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events (AEs) [Up to 6 months after infusion]
To evaluate the safety of SZ003 CAR-NK Cells
- Objective response rate (ORR) [Up to 6 months after infusion]
To evaluate the ORR of SZ003 CAR-NK Cells
- Overall survival (OS) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ003 CAR-NK Cells
Eligibility Criteria
Criteria
Inclusion Criteria:
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With advanced hepatocellular carcinoma (HCC) confirmed by histopathology;
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With stage C according to the Barcelona liver cancer grading criteria (BCLC) or with stage B who are ineligible for locoregional/locoregional therapy progression;
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Unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy;
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Through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (GPC3) ;
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With at least one stable evaluable target lesion according to RECIST 1.1 criteria, which was defined as: non-nodal lesion longest diameter ≥10 mm, or nodal lesion short diameter ≥15 mm;
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Age 18-80, male or female;
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Karnofsky Performance Status (KPS)≥80;
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Stable vital signs and expected survival at least 12 weeks.
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If HBsAg or HBcAb is positive, HBV-DNA < 200 IU/ml and to receive anti-HBV therapy ((Entecavir or tenofovirdisoproxil) for at least 14 days prior to the start of study treatment;
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Blood Routine: WBC≥2.5×109/L, PLT≥60×109/L, Hb≥9.0g/dL, LY≥0.4×109/L;
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Blood biochemistry: Alb≥30g/L, Lipase and Amylase ≤1.5 ULN, Serum creatinine ≤1.5 ULN, creatinine clearance ≥40mL/min, ALT≤5 ULN, AST≤5 ULN, Total Serum bilirubin ≤2.5 ULN, prothrombin time ≤6s;
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Be able to understand and sign an informed consent form
Exclusion Criteria:
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With uncontrolled active infections;
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No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation.
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With previous history of encephalopathy.
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With active acute or chronic virus, germ infection;
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Diagnosed with HIV infection or active hepatitis, HBV, HCV infection or other serious infectious diseases;
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Other serious medical conditions that may limit participation in the trial (such as poorly controlled diabetes (treated Glycated hemoglobin HbA1c > 7%) , severe heart failure (left ventricular ejection fraction (LVEF) < 45%) , myocardial infarction or unstable arrhythmia or unstable angina in the last 6 months, pulmonary embolism, chronic obstructive pulmonary disease, Interstitial lung disease, pulmonary function test FEV1 < 60% predicted, gastric ulcer, history of gastrointestinal bleeding, or definite gastrointestinal bleeding tendency) ;
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Ascites more than 5cm;
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The proportion of liver replaced by tumor≥70%, or with tumor infiltration in the portal vein, hepatic veins or inferior vena cava that completely blocks circulation in liver;
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Prior solid organ transplantation or waiting for organ transplantation (including liver transplantation);
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Prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy.
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Long-term systemic steroid therapy or patients with autoimmune diseases;
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With a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study;
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Have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation.
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Had received cell therapy previously but ineffective,after physical examination not allowed to received CAR-NK therapy by investigator's judgement;
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Pregnant or lactating women;
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Inappropriate to participate in this clinical trial by investigator's judgement.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shantou University Medical College
- Guangdong ProCapZoom Biosciences Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PCZCTP-220808-001