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

Advanced Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05845502
• Other study ID #: PCZCTP-220808-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: May 4, 2025

Study information

• Verified date: April 2023
• Source: Shantou University Medical College
• Contact: Yao KaiTao
• Phone: 15916672606
• Email: 42403153[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 4, 2025
• Est. primary completion date: May 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shantou University Medical College	Guangdong ProCapZoom Biosciences Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Adverse Events (AEs)	To evaluate the safety of SZ003 CAR-NK Cells	Up to 6 months after infusion
Primary	Objective response rate (ORR)	To evaluate the ORR of SZ003 CAR-NK Cells	Up to 6 months after infusion
Primary	Overall survival (OS)	To determine the anti-tumor effectivity of SZ003 CAR-NK Cells	Up to 6 months after infusion