Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer
Study Details
Study Description
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 SZ011 in the treatment of advanced triple-negative breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SZ011 CAR-NK
|
Drug: SZ011 CAR-NK
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events (AEs) [Up to 6 months after infusion]
To evaluate the safety of SZ011 CAR-NK Cells
- Objective response rate (ORR) [Up to 6 months after infusion]
To evaluate the ORR of SZ011 CAR-NK Cells
Secondary Outcome Measures
- Overall survival (OS) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
- Disease control rate (DCR) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
- Progression-free survival (PFS) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
- Duration of remission (DOR) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients voluntarily join the study, sign the informed consent form, and have willingness and ability to comply with study procedures.
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Female ≥ 18 years.
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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).
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The tumor tissue shows positive mesothelin (MESO) detected by immunohistochemistry.
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At least one target lesion that can be stably evaluated at baseline as per the solid tumor efficacy evaluation criteria (RECIST v1.1).
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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.
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Estimated survival time ≥ 12 weeks.
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Important organ function meets the following requirements:
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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;
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Blood biochemistry test:
Liver functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, alkaline phosphatase (ALP)
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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
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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.
Exclusion Criteria:
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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.
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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.
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The patient with moderate to large amount of pleural effusion, intraperitoneal effusion or pericardial effusion that cannot be controlled and need repeated drainage.
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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.
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The patient has other active virus and bacterial infection with significant clinical significance or systemic fungal infection that cannot be controlled.
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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+).
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Anyone who is diagnosed with congenital or acquired immunodeficiency (such as HIV-infected), or active hepatitis (HBV, HCV) infection, or other serious infectious diseases.
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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.
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Patients with a history of allergy to any component of cell products.
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Anyone who has participated in or is participating in other clinical trials within three months.
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Pregnant or lactating women.
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Anyone who was considered by the investigator to be unsuitable to participate in this clinical trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shantou | Shantou | China | GuangDong |
Sponsors and Collaborators
- First Affiliated Hospital of Shantou University Medical College
- Guangdong ProCapZoom Biosciences Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PCZCTP-220702-001