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

NCT05856643 | Recruiting Early Phase 1

• 1 other identifier: PCZCTP-230316-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

SZ011 CAR-NK

EXPERIMENTAL

Drug: SZ011 CAR-NK

Interventions

SZ011 CAR-NK 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.

SZ011 CAR-NK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shantou University Medical College: lead
• Guangdong ProCapZoom Biosciences Co., Ltd.: collaborator

Study Sites (1)

Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

ChongZhu Li, PhD

CONTACT

13923998618; czli2013@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 12, 2023
• Study Start: August 13, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 30, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)