Ovarian Epithelial Carcinoma
Conditions
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
Interventions
DRUGSZ011 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.
Sponsors
Guangdong ProCapZoom Biosciences Co., Ltd.
Shantou University Medical College
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactChongZhu Li, PhD
Outcome results
None listed