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

Primary Purpose

Ovarian Epithelial Carcinoma

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
SZ011 CAR-NK
Sponsored by
Shantou University Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Epithelial Carcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    SZ011 CAR-NK

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 3, 2023
    Last Updated
    May 3, 2023
    Sponsor
    Shantou University Medical College
    Collaborators
    Guangdong ProCapZoom Biosciences Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05856643
    Brief Title
    Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial Carcinoma
    Official Title
    Single-arm, Open-label Clinical Study of SZ011 in the Treatment of Ovarian Epithelial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shantou University Medical College
    Collaborators
    Guangdong ProCapZoom Biosciences Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Epithelial Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SZ011 CAR-NK
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SZ011 CAR-NK
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Adverse Events (AEs)
    Description
    To evaluate the safety of SZ011 CAR-NK Cells
    Time Frame
    Up to 6 months after infusion
    Title
    Objective response rate (ORR)
    Description
    To evaluate the ORR of SZ011 CAR-NK Cells
    Time Frame
    Up to 6 months after infusion
    Title
    Overall survival (OS)
    Description
    To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
    Time Frame
    Up to 6 months after infusion
    Title
    Progression-free survival (PFS)
    Description
    To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
    Time Frame
    Up to 6 months after infusion

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ChongZhu Li, PhD
    Phone
    13923998618
    Email
    czli2013@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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