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

Early Phase 1

Recruiting

• Conditions: Ovarian Epithelial Carcinoma
• Interventions: Drug: SZ011 CAR-NK

• Registration Number: NCT05856643
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Study Start: 2024-08-13
• Last Update Posted: 2024-08-13
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SZ011 CAR-NK	SZ011 CAR-NK	-

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	Up to 6 months after infusion	To evaluate the safety of SZ011 CAR-NK Cells
Objective response rate (ORR)	Up to 6 months after infusion	To evaluate the ORR of SZ011 CAR-NK Cells
Overall survival (OS)	Up to 6 months after infusion	To determine the anti-tumor effectivity of SZ011 CAR-NK Cells
Progression-free survival (PFS)	Up to 6 months after infusion	To determine the anti-tumor effectivity of SZ011 CAR-NK Cells

Trial Locations

Locations (1)

Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China