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

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

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

Study Overview

• Status: Recruiting
• Conditions: Ovarian Epithelial Carcinoma
• Intervention / Treatment: Drug: SZ011 CAR-NK

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: ChongZhu Li, PhD; Phone Number: 13923998618; Email: czli2013@163.com

Study Locations

• China
  • Guangdong
    • Shantou, Guangdong, China
      • Recruiting
      • Shantou University Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shantou University Medical College
• Collaborators: Guangdong ProCapZoom Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 13, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Ovarian Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Carcinoma; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: PCZCTP-230316-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No