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
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 ;
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.
Single group
SZ011 CAR-NK
DrugIn 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.
Number of Adverse Events (AEs)
To evaluate the safety of SZ011 CAR-NK Cells
Objective response rate (ORR)
To evaluate the ORR of SZ011 CAR-NK Cells
Overall survival (OS)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Progression-free survival (PFS)
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
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Shantou University Medical College
Lead sponsor
Guangdong ProCapZoom Biosciences Co., Ltd.
Collaborator
