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

Study Overview
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Brief Summary
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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

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

Conditions
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Ovarian Epithelial Carcinoma

Intervention / Treatment
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* Drug: SZ011 CAR-NK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SZ011 CAR-NK<br> | Drug: SZ011 CAR-NK<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events (AEs) | To evaluate the safety of SZ011 CAR-NK Cells | Up to 6 months after infusion | 
| Objective response rate (ORR) | To evaluate the ORR of SZ011 CAR-NK Cells | Up to 6 months after infusion | 
| Overall survival (OS) | To determine the anti-tumor effectivity of SZ011 CAR-NK Cells | Up to 6 months after infusion | 
| Progression-free survival (PFS) | To determine the anti-tumor effectivity of SZ011 CAR-NK Cells | Up to 6 months after infusion |