Ovary Cancer
Conditions
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.
Interventions
BIOLOGICALMETR-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.
Sponsors
Anhui Kecheng intelligent health technology Co., LTD
Anhui Provincial Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The remission rate of bone marrow suppression | 3-month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 12-month | Any adverse medical event that occurred after the subject received the trial drug |
Countries
China
Outcome results
None listed