NCT05856643招募中早期 1 期
Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial
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: 2024年8月13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
- 招募中
- 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 ovarian epithelial carcinoma
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
- •Females aged 18-80;
- •Histologically confirmed ovarian epithelial carcinoma;
- •Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;
- •At least one measurable lesion according to RECIST 1.1 ;
- •Positive expression of mesothelin in ovarian cancer tumors;
- •Functional status score (KPS) ≥80;
- •Expected survival ≥28 weeks;
- •The function of important organs meets the following requirements: absolute neutrophil count ≥1.5×109/L; platelets count ≥50×109/L; hemoglobin ≥80g/L; serum albumin ≥2.5g/dL; bilirubin ≤1.5 times ULN; ALT and AST ≤3 times ULN; serum creatinine ≤1.5 times ULN;
- •Able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
- •The subject or their partner agrees to take the contraceptive measures recognized by the trial within 1 month after signing the informed consent form until the end of the study.
排除标准
- •Exclusion criteria include those who have had other malignant tumors within the past 5 years, except for those who have been cured of basal cell carcinoma, cervical carcinoma in situ, and breast cancer that has not recurred for >3 years after radical surgery.
- •Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.
- •Patients who have experienced arterial thromboembolic events (including myocardial infarction, cardiac arrest, cerebrovascular accident, ischemic stroke, deep venous thrombosis of CTCAE 5.0 grade ≥3) or a history of pulmonary embolism within 6 months prior to enrollment are excluded.
- •Patients with a history of serious bleeding disorder within 6 months prior to screening, or those with a clear tendency to bleed (such as esophageal varices at risk of bleeding, active ulcer lesions, fecal occult blood >2+) as judged by the investigator, are excluded.
- •Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.
- •Patients with clinically significant cardiovascular disease:
- •Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110mmHg) despite treatment;
- •History of myocardial infarction or unstable angina pectoris within 6 months prior to enrollment;
- •Congestive heart failure or NYHA class II heart failure;
- •Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial fibrillation that is controllable.
- •Pregnant or lactating women are excluded.
- •Those who have participated in or are currently participating in other clinical trials within the past three months are excluded.
- •Patients considered unsuitable for this clinical trial by the investigator are excluded.
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
Overall survival (OS)
时间窗: Up to 6 months after infusion
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Progression-free survival (PFS)
时间窗: Up to 6 months after infusion
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
次要结局
未报告次要终点
研究者
Li Congzhu
Chief physician
Shantou University Medical College
研究点 (1)
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