An Exploratory Study on NK Cell-assisted Prevention of Bone Marrow Suppression During Chemotherapy for Ovarian Cancer

NCT ID: NCT07096583

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2027-07-30

Brief Summary

To evaluate the remission effect and safety of intravenous injection of METR-NK cells as adjuvant therapy on bone marrow suppression in patients with ovarian cancer after chemotherapy

Detailed Description

100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.

Conditions

Ovary Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

METR-NK cell（metabolic remodeling nature killer cells）

100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.

Group Type: EXPERIMENTAL

METR-NK cell（metabolic remodeling nature killer cells）

Intervention Type: BIOLOGICAL

100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.

Interventions

METR-NK cell（metabolic remodeling nature killer cells）

100 mL METR-NK cells were diluted in 500 mL 0.9% sodium chloride normal saline at 37℃, and the infusion volume of METR-NK cells was not less than 2×107 cells/kg for 1 day as a course of treatment, and the infusion time was maintained for 30 minutes on the 10th day before chemotherapy.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Age 18-70 years old (≥18, ≤70);
• Confirmed by pathology of high grade serous ovarian cancer, high level of endometrial carcinoma, and/or primary peritoneal carcinoma fallopian tube carcinoma epithelial ovarian cancer;
• ECOG score: 0-1;
• before, during, and after treatment of blood specimen can obtain, and the participants agreed to expand blood samples to central laboratory for the trial research purposes.;
• Expectations alive at least 3 months;
• Laboratory examination indexes meet the following requirements
• (1) renal function: Cr ULN or less (upper limit of normal) x 1.5, endogenous creatinine clearance rate (Ccr) or 60 ml/min;
• (2) the liver function: the total bilirubin ULN x 1.5 or less; ALT and AST≤ULN×2.5; (If there is intrahepatic cholangiocarcinoma or liver metastasis, the total bilirubin level should be less than 3 times the upper limit of normal, and the aminotransferase level should be less than 5 times the upper limit of normal); The neutrophilic granulocyte count
• Women of childbearing age agreed to during the study and research within 6 months after the end of contraception, And non-lactating patients;
• Participants can understand the research situation and voluntarily signed informed consent. No serious complications such as active digestive tract hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever > 38 ℃;
• Expected, adherence to the good curative effect and adverse reaction will be effected according to the plan calls for follow-up

Exclusion Criteria

• Patients had received drugs that were in other clinical trials or other cellular immunotherapies within 28 days before the screening period;
• Patients with other malignant tumours in the past five years.;
• Acute illness is ongoing, or in the past 2 years with severe disease, such as active infection, cardiovascular disease or fever patients heart function (grade III or IV level), mental health problems (such as alcohol, drugs).;
• Immunodeficiency disease, including HIV positive or suffering from other acquired and congenital immunodeficiency disease;
• Organ transplantation, organ transplantation or organ failure patients undergoing immunosuppressive medication or long-term use of immunosuppressive drugs patients;
• Move/vein thrombosis incidents happened in 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism;
• In patients with known to METR NK preparation any component of the final product, including the human serum albumin;
• Breastfeeding during screening serum or urine pregnancy test was positive in female;
• subjects suffering from mental illness, including major depression, mania, epilepsy, dementia, etc;
• Researchers say the other condition that doesn't fit into the group.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Kecheng intelligent health technology Co., LTD

UNKNOWN

Sponsor Role: collaborator

Anhui Provincial Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bai-Rong Xia

Director of Gynecological Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Cancer Hospitail

Hefei, Anhui, China

Countries

China

Other Identifiers

2025-LLYJ-0036

Identifier Type: -

Identifier Source: org_study_id