Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer

Trial Title: Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer

NCT ID: NCT06395844

Condition: Ovarian Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: METR-NK cell(Metabolic Remodeling Nature Killer Cells)
Description: The minimum amount of METR-NK cells infused each time should be no less than 7.5×10^7 cells, Continuous infusion for 2 days constitutes one course, with 4 courses. The infusion is given every 2 weeks.
Arm group label: METR-NK cell（metabolic remodeling nature killer cells）

Summary: The goal of this type of clinical trial study is to evaluate the safety and efficacy of metabolic remodeling nature killer cells as neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer

Detailed description: Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells (PBMc) will be isolated and purified for NK manufacturing. The addition of key metabolic molecules in the medium remodeled the metabolic network of NK cells, significantly reduced the aging phenomenon of NK cells in the culture process, improved the cell activity of NK cells and enhanced the cytotoxicity of NK cells. After 14 days cultivation, activated METR-NK will be harvested and formulated for clinical administration.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age: 18-70 years old (≥18, ≤70); - Open surgery, laparoscopic surgery, or coarse needle biopsy for histopathological confirmation of advanced (FIGO IIIC/IV stage) high-grade serous ovarian cancer, high-grade endometrioid carcinoma, primary peritoneal carcinoma, and/or fallopian tube carcinoma, etc.; - ECOG score: 0-1; - Blood and tissue specimens before, during, and after treatment can be obtained, and subjects agree to submit blood and tissue specimens to the central laboratory for the purpose of expanding research in this trial; - At least one lesion measurable by CT/MRI according to RECIST 1.1 criteria; - Expected survival of at least 3 months; - Patients judged by professional gynecologic oncologists as unable to achieve R0 resection or intolerant to surgery. - Criteria for determining inability to achieve R0 resection include but are not limited to: Fagotti laparoscopic score ≥8 points; When laparoscopic evaluation is difficult to implement, an upper abdominal CT score ≥3 points may be used; - Criteria for intolerance to surgery may include: Advanced age: age ≥70; Body mass index: BMI ≥40.0; Multiple chronic diseases; Malnutrition or hypoalbuminemia; Moderate to large amount of ascites; Newly diagnosed venous thromboembolism (survival period greater than 12 weeks); - Major organ function meets the following criteria within 7 days before treatment: Hematological examination: Hemoglobin ≥90g/L, white blood cell count ≥3×10^9/L, absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets ≥90×10^9/L; Kidney: Serum creatinine <1.5 mg/dL, glomerular filtration rate (GFR) ≥50 ml/min (based on the Fairview Laboratories formula at screening); Liver: AST, ALT, and alkaline phosphatase <3 times the upper limit of normal for the institution, total bilirubin <1.5 times the upper limit of normal for the institution; Lung function: Resting oxygen saturation ≥90%; Cardiac function: Left ventricular ejection fraction (LVEF) ≥40% by echocardiography, MUGA, or cardiac MRI; no evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, or acute ischemia or active conduction system abnormalities on electrocardiography; - No history of intestinal obstruction within two months; - Reproductive-age patients must take effective contraceptive measures; - Subjects voluntarily join this study and sign an informed consent form (ICF); - Good compliance is expected, and subjects are able to follow up on efficacy and adverse reactions as required by the protocol. Exclusion Criteria: - Patients who have received drugs or other cell immunotherapy in other clinical trials within 28 days before the screening period; - Patients who have had other malignant tumors in the past 5 years; - Acute illnesses are ongoing, or severe illnesses have occurred in the past 2 years, such as patients with active infections or fever, cardiovascular diseases (Grade III or IV heart failure), mental health issues (such as alcoholism, drug abuse); - History of immunodeficiency, including HIV-positive status or other acquired, congenital immunodeficiency diseases; - Organ transplant or organ failure patients, patients receiving immunosuppressive therapy after organ transplantation, or patients taking immunosuppressive drugs long-term; - Thromboembolic events such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism within 6 months; - Known allergy to any component of the final product of METR-NK preparation, including human serum albumin; - Breastfeeding during the screening period or female subjects with positive serum or urine pregnancy tests; - Patients with mental illnesses, including epilepsy, dementia, severe depression, bipolar disorder, etc.; - Other conditions deemed unsuitable for inclusion by the investigator.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Anhui Cancer Hospital

Address:
City: Hefei
Country: China

Status: Recruiting

Contact:
Last name: Bai-Rong Xia

Phone: 18604516165
Email: xiabairong9999@126.com

Contact backup:
Last name: Yao Chen

Phone: 18379859820
Email: 1969354224@qq.com

Start date: May 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Anhui Provincial Cancer Hospital
Agency class: Other

Collaborator:
Agency: Anhui Kecheng intelligent health technology Co., LTD
Agency class: Other

Source: Anhui Provincial Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06395844