Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT05845502
Status:
TERMINATED
Last Update Posted:
2025-01-29
First Post:
2023-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Failed to recruit more volunteers', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2023-04-25', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rates and severity of AEs', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To evaluate the safety of SZ003 CAR-NK Cells'}], 'secondaryOutcomes': [{'measure': 'overall survival (OS)', 'timeFrame': 'up to 2 years', 'description': 'To determine the anti-tumor effectivity of SZ003 CAR-NK Cells'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'To determine the anti-tumor effectivity of SZ003 CAR-NK Cells'}, {'measure': 'disease control rate (DCR) and objective response rate (ORR)', 'timeFrame': 'up to 2 years', 'description': 'To determine the anti-tumor effectivity of SZ003 CAR-NK Cells'}, {'measure': 'duration of response (DOR)', 'timeFrame': 'up to 2 years', 'description': 'To determine the anti-tumor effectivity of SZ003 CAR-NK Cells'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. With advanced hepatocellular carcinoma (HCC) confirmed by histopathology;\n2. With stage C according to the Barcelona liver cancer grading criteria (BCLC) or with stage B who are ineligible for locoregional/locoregional therapy progression;\n3. Unsuitable for surgery or local therapy (including ablation, interventional and radiotherapy) and who have experienced progression or intolerance after previous standard therapy;\n4. Through immune tissues chemistry, confirmation of tumor cells positive expression of relevant molecular targets (GPC3) ;\n5. 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;\n6. Age 18-80, male or female;\n7. Karnofsky Performance Status (KPS)≥80;\n8. Stable vital signs and expected survival at least 12 weeks.\n9. 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;\n10. Blood Routine: WBC≥2.5×109/L, PLT≥60×109/L, Hb≥9.0g/dL, LY≥0.4×109/L;\n11. 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;\n12. Be able to understand and sign an informed consent form\n\nExclusion Criteria:\n\n1. With uncontrolled active infections;\n2. No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within 5 years before study treatment initiation.\n3. With previous history of encephalopathy.\n4. With active acute or chronic virus, germ infection;\n5. Diagnosed with HIV infection or active hepatitis, HBV, HCV infection or other serious infectious diseases;\n6. 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) ;\n7. Ascites more than 5cm;\n8. 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;\n9. Prior solid organ transplantation or waiting for organ transplantation (including liver transplantation);\n10. Prior anti-tumor therapies within 14 days before study treatment initiation, such as surgery, interventional therapy, radiotherapy, chemotherapy, immunotherapy.\n11. Long-term systemic steroid therapy or patients with autoimmune diseases;\n12. With a history of allergic reactions attributed to compounds of similar chemical or biological composition used in the study;\n13. Have participation in clinical trials of any other investigational agents within 3 months before study treatment initiation.\n14. Had received cell therapy previously but ineffective,after physical examination not allowed to received CAR-NK therapy by investigator's judgement;\n15. Pregnant or lactating women;\n16. Inappropriate to participate in this clinical trial by investigator's judgement."}, 'identificationModule': {'nctId': 'NCT05845502', 'briefTitle': 'Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shantou University Medical College'}, 'officialTitle': 'Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'PCZCTP-220808-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SZ003 CAR-NK', 'interventionNames': ['Biological: SZ003 CAR-NK']}], 'interventions': [{'name': 'SZ003 CAR-NK', 'type': 'BIOLOGICAL', '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.', 'armGroupLabels': ['SZ003 CAR-NK']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shantou University Medical College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangdong ProCapZoom Biosciences Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director', 'investigatorFullName': 'Yao KaiTao', 'investigatorAffiliation': 'Shantou University Medical College'}}}}