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

NCT05845502 | Terminated

• 1 other identifier: PCZCTP-220808-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The incidence rates and severity of AEs

  To evaluate the safety of SZ003 CAR-NK Cells

  through study completion, an average of 1 year

Secondary Outcomes (4)

• overall survival (OS)

  up to 2 years

• progression-free survival (PFS)

  up to 2 years

• disease control rate (DCR) and objective response rate (ORR)

  up to 2 years

• duration of response (DOR)

  up to 2 years

Study Arms (1)

SZ003 CAR-NK

EXPERIMENTAL

Biological: SZ003 CAR-NK

Interventions

SZ003 CAR-NK 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.

SZ003 CAR-NK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With advanced hepatocellular carcinoma (HCC) confirmed by histopathology;
• With stage C according to the Barcelona liver cancer grading criteria (BCLC) or with stage B who are ineligible for locoregional/locoregional therapy progression;
• Unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy;
• Through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (GPC3) ;
• 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;
• Age 18-80, male or female;
• Karnofsky Performance Status (KPS)≥80;
• Stable vital signs and expected survival at least 12 weeks.
• 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;
• Blood Routine: WBC≥2.5×109/L, PLT≥60×109/L, Hb≥9.0g/dL, LY≥0.4×109/L;
• 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;
• Be able to understand and sign an informed consent form

You may not qualify if:

• With uncontrolled active infections;
• No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation.
• With previous history of encephalopathy.
• With active acute or chronic virus, germ infection;
• Diagnosed with HIV infection or active hepatitis, HBV, HCV infection or other serious infectious diseases;
• 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) ;
• Ascites more than 5cm;
• 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;
• Prior solid organ transplantation or waiting for organ transplantation (including liver transplantation);
• Prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy.
• Long-term systemic steroid therapy or patients with autoimmune diseases;
• With a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study;
• Have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation.
• Had received cell therapy previously but ineffective,after physical examination not allowed to received CAR-NK therapy by investigator's judgement;
• Pregnant or lactating women;

Sponsors & Collaborators

• Shantou University Medical College: lead
• Guangdong ProCapZoom Biosciences Co., Ltd.: collaborator

Study Sites (1)

Shantou University Medical College

Shantou, Guangdong, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: July 26, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

CN (1)