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

NCT ID: NCT05845502

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2024-09-30

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.

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SZ003 CAR-NK

Group Type: EXPERIMENTAL

SZ003 CAR-NK

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong ProCapZoom Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shantou University Medical College

OTHER

Sponsor Role: lead

Responsible Party

Yao KaiTao

Deputy Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shantou University Medical College

Shantou, Guangdong, China

Countries

China

Other Identifiers

PCZCTP-220808-001

Identifier Type: -

Identifier Source: org_study_id