Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma

Trial Title: Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma

NCT ID: NCT05845502

Condition: Advanced Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: SZ003 CAR-NK
Description: 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.
Arm group label: SZ003 CAR-NK

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. With advanced hepatocellular carcinoma (HCC) confirmed by histopathology; 2. With stage C according to the Barcelona liver cancer grading criteria (BCLC) or with stage B who are ineligible for locoregional/locoregional therapy progression; 3. Unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy; 4. Through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (GPC3) ; 5. 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; 6. Age 18-80, male or female; 7. Karnofsky Performance Status (KPS)≥80; 8. Stable vital signs and expected survival at least 12 weeks. 9. 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; 10. Blood Routine: WBC≥2.5×109/L, PLT≥60×109/L, Hb≥9.0g/dL, LY≥0.4×109/L; 11. 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; 12. Be able to understand and sign an informed consent form Exclusion Criteria: 1. With uncontrolled active infections; 2. No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation. 3. With previous history of encephalopathy. 4. With active acute or chronic virus, germ infection; 5. Diagnosed with HIV infection or active hepatitis, HBV, HCV infection or other serious infectious diseases; 6. 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) ; 7. Ascites more than 5cm; 8. 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; 9. Prior solid organ transplantation or waiting for organ transplantation (including liver transplantation); 10. Prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy. 11. Long-term systemic steroid therapy or patients with autoimmune diseases; 12. With a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study; 13. Have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation. 14. Had received cell therapy previously but ineffective,after physical examination not allowed to received CAR-NK therapy by investigator's judgement; 15. Pregnant or lactating women; 16. Inappropriate to participate in this clinical trial by investigator's judgement.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shantou University Medical College

Address:
City: Shantou
Country: China

Status: Recruiting

Start date: August 13, 2024

Completion date: May 4, 2025

Lead sponsor:
Agency: Shantou University Medical College
Agency class: Other

Collaborator:
Agency: Guangdong ProCapZoom Biosciences Co., Ltd.
Agency class: Industry

Source: Shantou University Medical College

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05845502