Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05856643
Other study ID # PCZCTP-230316-002
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2025

Study information

Verified date May 2023
Source Shantou University Medical College
Contact ChongZhu Li, PhD
Phone 13923998618
Email czli2013@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date December 30, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 80 Years
Eligibility 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


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shantou University Medical College Guangdong ProCapZoom Biosciences Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events (AEs) To evaluate the safety of SZ011 CAR-NK Cells Up to 6 months after infusion
Primary Objective response rate (ORR) To evaluate the ORR of SZ011 CAR-NK Cells Up to 6 months after infusion
Primary Overall survival (OS) To determine the anti-tumor effectivity of SZ011 CAR-NK Cells Up to 6 months after infusion
Primary Progression-free survival (PFS) To determine the anti-tumor effectivity of SZ011 CAR-NK Cells Up to 6 months after infusion
See also
  Status Clinical Trial Phase
Completed NCT01536743 - A Open Label Study of the Efficacy and Safety of PD0332991 a Selective Inhibitor of the Cyclin Dependent Kinases 4 and 6 in Patients With Recurrent Ovarian Cancer Demonstrating Rb-proficiency and Low p16 Expression Phase 2
Recruiting NCT05763199 - Standardized Extract of Cultured Lentinula Edodes Mycelia (AHCC®) in Ovarian Cancer Patients on Adjuvant Chemotherapy Phase 2
Recruiting NCT04794322 - Developing a Test for the Detection of Ovarian Cancer