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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05856643
Recruitment Status : Not yet recruiting
First Posted : May 12, 2023
Last Update Posted : May 12, 2023
Guangdong ProCapZoom Biosciences Co., Ltd.
Information provided by (Responsible Party):
Li Congzhu, Shantou University Medical College

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
Ovarian Epithelial Carcinoma Drug: SZ011 CAR-NK Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Number of Adverse Events (AEs) [ Time Frame: Up to 6 months after infusion ]
    To evaluate the safety of SZ011 CAR-NK Cells

  2. Objective response rate (ORR) [ Time Frame: Up to 6 months after infusion ]
    To evaluate the ORR of SZ011 CAR-NK Cells

  3. Overall survival (OS) [ Time Frame: Up to 6 months after infusion ]
    To determine the anti-tumor effectivity of SZ011 CAR-NK Cells

  4. Progression-free survival (PFS) [ Time Frame: Up to 6 months after infusion ]
    To determine the anti-tumor effectivity of SZ011 CAR-NK Cells

Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. Females aged 18-80;
  2. Histologically confirmed ovarian epithelial carcinoma;
  3. Ovarian cancer patients who have failed or relapsed after first-line treatment, with or without other treatments;
  4. At least one measurable lesion according to RECIST 1.1 ;
  5. Positive expression of mesothelin in ovarian cancer tumors;
  6. Functional status score (KPS) ≥80;
  7. Expected survival ≥28 weeks;
  8. 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;
  9. Able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
  10. 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:

  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.
  2. Patients known to have central nervous system metastasis or leptomeningeal disease are excluded.
  3. 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.
  4. 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.
  5. Patients with congenital or acquired immunodeficiency (such as HIV infection), active hepatitis B or C virus infection, or other severe infectious diseases are excluded.
  6. Patients with clinically significant cardiovascular disease:

    1. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥110mmHg) despite treatment;
    2. History of myocardial infarction or unstable angina pectoris within 6 months prior to enrollment;
    3. Congestive heart failure or NYHA class II heart failure;
    4. Severe symptomatic arrhythmia requiring medication, excluding asymptomatic atrial fibrillation that is controllable.
  7. Pregnant or lactating women are excluded.
  8. Those who have participated in or are currently participating in other clinical trials within the past three months are excluded.
  9. Patients considered unsuitable for this clinical trial by the investigator are excluded.

Information from the National Library of Medicine

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

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Contact: ChongZhu Li, PhD 13923998618 czli2013@163.com

Sponsors and Collaborators
Shantou University Medical College
Guangdong ProCapZoom Biosciences Co., Ltd.
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Responsible Party: Li Congzhu, Chief physician, Shantou University Medical College
ClinicalTrials.gov Identifier: NCT05856643    
Other Study ID Numbers: PCZCTP-230316-002
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders