Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma

Официальное название

Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial

Обзор

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

Вмешательства

• Препарат SZ011 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\^8and 5.0×10\^8 cells. The infusion is given every 2 weeks.

Первичные конечные точки

• Number of Adverse Events (AEs) [Срок оценки: Up to 6 months after infusion]
• Objective response rate (ORR) [Срок оценки: Up to 6 months after infusion]
• Overall survival (OS) [Срок оценки: Up to 6 months after infusion]
• Progression-free survival (PFS) [Срок оценки: Up to 6 months after infusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shantou University Medical College — Shantou

Идентификаторы

NCT: NCT05856643 · PCZCTP-230316-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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