Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SZ011 CAR-NK
|
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Number of Adverse Events (AEs) [Up to 6 months after infusion]
To evaluate the safety of SZ011 CAR-NK Cells
- Objective response rate (ORR) [Up to 6 months after infusion]
To evaluate the ORR of SZ011 CAR-NK Cells
- Overall survival (OS) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
- Progression-free survival (PFS) [Up to 6 months after infusion]
To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Eligibility Criteria
Criteria
Inclusion Criteria:
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Females aged 18-80;
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Histologically confirmed ovarian epithelial carcinoma;
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Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;
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At least one measurable lesion according to RECIST 1.1 ;
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Positive expression of mesothelin in ovarian cancer tumors;
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Functional status score (KPS) ≥80;
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Expected survival ≥28 weeks;
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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;
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Able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
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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:
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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.
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Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.
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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.
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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.
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Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.
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Patients with clinically significant cardiovascular disease:
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Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110mmHg) despite treatment;
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History of myocardial infarction or unstable angina pectoris within 6 months prior to enrollment;
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Congestive heart failure or NYHA class II heart failure;
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Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial fibrillation that is controllable.
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Pregnant or lactating women are excluded.
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Those who have participated in or are currently participating in other clinical trials within the past three months are excluded.
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Patients considered unsuitable for this clinical trial by the investigator are excluded.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shantou University Medical College
- Guangdong ProCapZoom Biosciences Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PCZCTP-230316-002