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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-80
SponsorShantou University Medical College

About this trial

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

Eligibility criteria

Qualifiers

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 ;

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SZ011 CAR-NK

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shantou University Medical College

Lead sponsor

Guangdong ProCapZoom Biosciences Co., Ltd.

Collaborator