Advanced Hepatocellular CarcinomaNCT05845502
Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
A study testing SZ003 CAR-NK in people with Advanced Hepatocellular Carcinoma, run by Shantou University Medical College at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- SZ003 CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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) ;
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- 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;
- Inappropriate to participate in this clinical trial by investigator's judgement.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- SZ003 CAR-NK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZ003 CAR-NKBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| SZ003 CAR-NK | Experimental | Not described Receives: Biological: SZ003 CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rates and severity of AEs
To evaluate the safety of SZ003 CAR-NK Cells
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
overall survival (OS)
To determine the anti-tumor effectivity of SZ003 CAR-NK Cells
Measured: up to 2 years
progression-free survival (PFS)
To determine the anti-tumor effectivity of SZ003 CAR-NK Cells
Measured: up to 2 years
disease control rate (DCR) and objective response rate (ORR)
To determine the anti-tumor effectivity of SZ003 CAR-NK Cells
Measured: up to 2 years
duration of response (DOR)
To determine the anti-tumor effectivity of SZ003 CAR-NK Cells
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start26 Jul 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: Failed to recruit more volunteers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shantou University Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Responsible party
- Principal investigator, Yao KaiTao, Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05845502
- Sponsor's protocol ID
- PCZCTP-220808-001
- Status last verified
- Jan 2025
- First submitted
- 25 Apr 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open-label Clinical Study of SZ003 in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05845502
- Acronym / sponsor ID
- PCZCTP-220808-001
- Conditions
- Advanced Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failed to recruit more volunteers
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Shantou University Medical CollegeUniversity, hospital or other
- Collaborators
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SZ003 CAR-NK | Experimental | Biological: SZ003 CAR-NK |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SZ003 CAR-NKDrug: 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. | Biological | SZ003 CAR-NK |
Primary outcome
The incidence rates and severity of AEs
Time frame: through study completion, an average of 1 year
To evaluate the safety of SZ003 CAR-NK Cells
4 secondary outcomes
overall survival (OS)
Time frame: up to 2 years
progression-free survival (PFS)
Time frame: up to 2 years
disease control rate (DCR) and objective response rate (ORR)
Time frame: up to 2 years
duration of response (DOR)
Time frame: up to 2 years
Results and safety
The study was stopped early (reason given: Failed to recruit more volunteers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SZ003 CAR-NK in people with Advanced Hepatocellular Carcinoma, run by Shantou University Medical College at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Failed to recruit more volunteers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates and severity of AEs (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.