Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma
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|ClinicalTrials.gov Identifier: NCT05856643|
Recruitment Status : Not yet recruiting
First Posted : May 12, 2023
Last Update Posted : May 12, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Epithelial Carcinoma||Drug: SZ011 CAR-NK||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial|
|Estimated Study Start Date :||June 1, 2023|
|Estimated Primary Completion Date :||June 1, 2025|
|Estimated Study Completion Date :||December 30, 2025|
|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.
- Number of Adverse Events (AEs) [ Time Frame: Up to 6 months after infusion ]To evaluate the safety of SZ011 CAR-NK Cells
- Objective response rate (ORR) [ Time Frame: Up to 6 months after infusion ]To evaluate the ORR of SZ011 CAR-NK Cells
- Overall survival (OS) [ Time Frame: Up to 6 months after infusion ]To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
- Progression-free survival (PFS) [ Time Frame: Up to 6 months after infusion ]To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05856643
|Contact: ChongZhu Li, PhDfirstname.lastname@example.org|
|Responsible Party:||Li Congzhu, Chief physician, Shantou University Medical College|
|Other Study ID Numbers:||
|First Posted:||May 12, 2023 Key Record Dates|
|Last Update Posted:||May 12, 2023|
|Last Verified:||May 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases