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

NCT ID: NCT05856643

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-13
• Study Completion Date: 2025-12-30

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

Conditions

Ovarian Epithelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SZ011 CAR-NK

Group Type: EXPERIMENTAL

SZ011 CAR-NK

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangdong ProCapZoom Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Shantou University Medical College

OTHER

Sponsor Role: lead

Responsible Party

Li Congzhu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shantou University Medical College

Shantou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

ChongZhu Li, PhD

Role: CONTACT

czli2013@163.com

13923998618

Other Identifiers

PCZCTP-230316-002

Identifier Type: -

Identifier Source: org_study_id