Menu
Recruiting NCT05856643

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

Early Phase I Interventional Ovarian Epithelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SZ011 CAR-NK.
Who it may be relevant to
Registry conditions: Ovarian Epithelial Carcinoma. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

  • Number of Adverse Events (AEs) [Time frame: Up to 6 months after infusion]
  • Objective response rate (ORR) [Time frame: Up to 6 months after infusion]
  • Overall survival (OS) [Time frame: Up to 6 months after infusion]
  • Progression-free survival (PFS) [Time frame: Up to 6 months after infusion]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Shantou University Medical College — Shantou

Identifiers

NCT: NCT05856643 · PCZCTP-230316-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗