NCT05686720尚未招募早期 1 期
Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Advanced Triple Negative Breast Cancer
First Affiliated Hospital of Shantou University Medical College1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2023年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
SZ011 CAR-NK
Experimental
干预措施: SZ011 CAR-NK (Drug)
结局指标
主要结局
Number of Adverse Events (AEs)
时间窗: Up to 6 months after infusion
To evaluate the safety of SZ011 CAR-NK Cells
Objective response rate (ORR)
时间窗: Up to 6 months after infusion
To evaluate the ORR of SZ011 CAR-NK Cells
次要结局
- Progression-free survival (PFS)(Up to 6 months after infusion)
- Disease control rate (DCR)(Up to 6 months after infusion)
- Duration of remission (DOR)(Up to 6 months after infusion)
- Overall survival (OS)(Up to 6 months after infusion)
研究者
Jing Lin
Deputy Director
First Affiliated Hospital of Shantou University Medical College
研究点 (1)
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