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

NCT07096583 | Active Not Recruiting Phase 1

• 1 other identifier: 2025-LLYJ-0036
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Ovary Cancer

Outcome Measures

Primary Outcomes (1)

• The remission rate of bone marrow suppression

  The objective of the study was to evaluate the efficacy and safety of NK cell adjuvant therapy in alleviating chemotherapy-induced myelosuppression in patients with ovarian cancer. The primary endpoints included the time to neutrophil recovery, the improvement rate of platelet count, and the incidence of infectious events

  3-month

Secondary Outcomes (1)

• Adverse event

  12-month

Study Arms (1)

METR-NK cell（metabolic remodeling nature killer cells）

EXPERIMENTAL

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.

Biological: METR-NK cell（metabolic remodeling nature killer cells）

Interventions

METR-NK cell（metabolic remodeling nature killer cells） 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.

METR-NK cell（metabolic remodeling nature killer cells）

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Cancer Hospital: lead
• Anhui Kecheng intelligent health technology Co., LTD: collaborator

Study Sites (1)

Anhui Cancer Hospitail

Hefei, Anhui, 230001, China

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gynecological Surgery

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)