Advanced Triple Negative Breast CancerEarly Phase 1NCT05686720
Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer
A Early Phase 1 study testing SZ011 CAR-NK in people with Advanced Triple Negative Breast Cancer, run by First Affiliated Hospital of 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 SZ011 in the treatment of advanced triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Advanced Triple Negative Breast Cancer
- What is being tested?
- SZ011 CAR-NK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Jun 2024
- Phase
- Early Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients voluntarily join the study, sign the informed consent form, and have willingness and ability to comply with study procedures.
- Female ≥ 18 years.
- Histologically confirmed advanced TNBC , namely, human epidermal growth receptor 2-negative (HER2-negative) and estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative).
- The tumor tissue shows positive mesothelin (MESO) detected by immunohistochemistry.
- At least one target lesion that can be stably evaluated at baseline as per the solid tumor efficacy evaluation criteria (RECIST v1.1).
- Progress after receiving second-line or above treatment in the past.
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- Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 points.
- Estimated survival time ≥ 12 weeks.
- Important organ function meets the following requirements:
- Blood routine test: neutrophil count (ANC) ≥1.5 × 109/L; Lymphocyte count (LC) ≥0.5×109/L; Platelet count (PLT) ≥75 × 109/L; Hemoglobin (HG) ≥ 90 g/L;
- Blood biochemistry test:
- Liver functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, alkaline phosphatase (ALP)
- 2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN; except in the following cases:For patients with liver metastasis: AST and/or ALT ≤5×ULN, TBIL
- 3×ULN; For patients with liver or bone metastasis: ALP≤5×ULN; Renal function: BUN and Cr ≤1.5×ULN and creatinine clearance ≥60 mL/min (Cockcroft-Gault formula).
- Women of childbearing potential must have a serum pregnancy test performed 7 days before the first dose and be assessed as non-pregnant. Female subjects of childbearing potential must agree to use an efficient method of contraception (e.g., an intrauterine device, contraceptive pill, or condom) within 4 weeks from the date of the informed consent form until the last dose of study drug.
Who cannot join
- The patient had other malignancies within the 5 years prior to screening, in addition to cured cervical carcinoma in situ, basal or squamous cell skin cancer, and postoperative ductal carcinoma in situ.
- Patients with active (without medical control or with clinical symptoms) brain metastasis, cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system.
- The patient with moderate to large amount of pleural effusion, intraperitoneal effusion or pericardial effusion that cannot be controlled and need repeated drainage.
- Patients with uncontrolled tumor-related pain judged by the researcher. Subjects in need of analgesic therapy must have a stable analgesic regimen in place by study entry. Symptomatic lesions suitable for palliative radiotherapy should be treated before entering the study.
- The patient has other active virus and bacterial infection with significant clinical significance or systemic fungal infection that cannot be controlled.
- Anyone who has had arterial thromboembolism events (including myocardial infarction, cardiac arrest, cerebrovascular accident, cerebral ischemia, and a history of deep vein thrombosis or pulmonary embolism of Class 3 or above by CTCAE5.0) within six months before enrollment.
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- Patients with a history of severe hemorrhagic disease within 6 months before enrollment, or those who were considered by the investigator to have a clear bleeding tendency (such as esophageal varices at risk for bleeding, locally active ulcer lesions, and fecal occult blood > 2+).
- Anyone who is diagnosed with congenital or acquired immunodeficiency (such as HIV-infected), or active hepatitis (HBV, HCV) infection, or other serious infectious diseases.
- With clinically significant cardiovascular disease: a) uncontrollable hypertension after treatment (systolic blood pressure ≥160mmHg and/ or diastolic blood pressure ≥110 mmHg); b) Has a history of myocardial infarction or unstable angina within 6 months before enrollment; c) Congestive heart failure or grade II heart failure; d) Arrhythmia in serious need of medical treatment, excluding asymptomatic atrial fibrillation with controllable heart rate.
- Patients with a history of allergy to any component of cell products.
- Anyone who has participated in or is participating in other clinical trials within three months.
- Pregnant or lactating women.
- Anyone who was considered by the investigator to be unsuitable to participate in this clinical trial.
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 SZ011 in the treatment of advanced triple-negative breast cancer.
- Conditions
- Advanced Triple Negative Breast Cancer
- Being tested
- SZ011 CAR-NK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZ011 CAR-NKDrug
In the escalation study, the minimum initial dose was 5.0×10^6 cells, then increased to 5.0×10^7 and 2.0×10^8 cells. The infusion is given every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| SZ011 CAR-NK | Experimental | Not described Receives: Drug: SZ011 CAR-NK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs)
To evaluate the safety of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Objective response rate (ORR)
To evaluate the ORR of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Secondary outcomes (4)
Overall survival (OS)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Disease control rate (DCR)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Progression-free survival (PFS)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Duration of remission (DOR)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Measured: Up to 6 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Triple Negative Breast CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Responsible party
- Principal investigator, Jing Lin, First Affiliated Hospital of Shantou University Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686720
- Sponsor's protocol ID
- PCZCTP-220702-001
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 17 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05686720
- Acronym / sponsor ID
- PCZCTP-220702-001
- Conditions
- Advanced Triple Negative Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Shantou University Medical CollegeUniversity, hospital or other
- Collaborators
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 17 Jan 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 SZ011 in the treatment of advanced triple-negative breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SZ011 CAR-NK | Experimental | Drug: SZ011 CAR-NK |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients voluntarily join the study, sign the informed consent form, and have willingness and ability to comply with study procedures.
- Female ≥ 18 years.
- Histologically confirmed advanced TNBC , namely, human epidermal growth receptor 2-negative (HER2-negative) and estrogen receptor-negative (ER-negative) and progesterone receptor-negative (PR-negative).
- The tumor tissue shows positive mesothelin (MESO) detected by immunohistochemistry.
- At least one target lesion that can be stably evaluated at baseline as per the solid tumor efficacy evaluation criteria (RECIST v1.1).
Key exclusion criteria (13 listed)
- The patient had other malignancies within the 5 years prior to screening, in addition to cured cervical carcinoma in situ, basal or squamous cell skin cancer, and postoperative ductal carcinoma in situ.
- Patients with active (without medical control or with clinical symptoms) brain metastasis, cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system.
- The patient with moderate to large amount of pleural effusion, intraperitoneal effusion or pericardial effusion that cannot be controlled and need repeated drainage.
- Patients with uncontrolled tumor-related pain judged by the researcher. Subjects in need of analgesic therapy must have a stable analgesic regimen in place by study entry. Symptomatic lesions suitable for palliative radiotherapy should be treated before entering the study.
- The patient has other active virus and bacterial infection with significant clinical significance or systemic fungal infection that cannot be controlled.
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 |
|---|---|---|
| SZ011 CAR-NKIn the escalation study, the minimum initial dose was 5.0×10^6 cells, then increased to 5.0×10^7 and 2.0×10^8 cells. The infusion is given every 2 weeks. | Drug | SZ011 CAR-NK |
Primary outcome
Number of Adverse Events (AEs)
Time frame: Up to 6 months after infusion
To evaluate the safety of SZ011 CAR-NK Cells
Objective response rate (ORR)
Time frame: Up to 6 months after infusion
To evaluate the ORR of SZ011 CAR-NK Cells
4 secondary outcomes
Overall survival (OS)
Time frame: Up to 6 months after infusion
Disease control rate (DCR)
Time frame: Up to 6 months after infusion
Progression-free survival (PFS)
Time frame: Up to 6 months after infusion
Duration of remission (DOR)
Time frame: Up to 6 months after infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SZ011 CAR-NK in people with Advanced Triple Negative Breast Cancer, run by First Affiliated Hospital of 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 15 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 17 Jan 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Lin, PhD (13531285809, 316603568@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) (time frame: Up to 6 months after infusion). The study lists 2 primary outcomes in all. 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 17 Jan 2023.