Epithelial ovarian carcinoma
Conditions
Interventions
Single arm:CAR-NK cell Infusion
Sponsors
Zhuhai People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with refractory epithelial ovarian cancer who failed or relapsed after first-line treatment; 2. Epithelial carcinoma of the ovary should be pathologically confirmed; 3. Female aged between 18 and 70 years; 4. At least one measurable lesion that meets RECIST 1.1 criteria; 5. Mesothelin (MESO) expression should be detected in ovarian cancer tumor tissue; 6. Functional status score (KPS) =60 points; 7. Expected survival >=28 weeks; 8. The functions of vital organs meet the following requirements: absolute neutrophils count >=1.5x10^9/L, Platelet >=100x10^9/L, Hemoglobin >=10g/dL; Serum albumin >=3g/dL, Bilirubin <=1.5 ULN, ALT and AST <=2.5 ULN, Serum creatinine <=1.5 ULN; 9. Able to understand informed consent, participate voluntarily and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors in the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and breast cancer without recurrence of > for 3 years after radical surgery; 2. Patients with known central nervous system metastases or pia meninges metastases; 3. Arteriorthromboembolic events (including myocardial infarction, cardiac arrest, cerebrovascular accident, cerebral ischemia, CTCAE5.0 grade 3 or above deep vein thrombosis or pulmonary embolism) occurred within 6 months before enrollment; 4. Those who had a history of hemorrhagic disease, or were taking anticoagulant drugs, or were considered by the investigator to have a definite bleeding tendency (such as esophageal varicose veins with bleeding risk, local active ulcer lesions, or stool occult blood > 2+) within 6 months before inclusion; 5. Patients with abnormal coagulation function, bleeding tendency or receiving thrombolysis or anticoagulant therapy; 6. Diagnosed with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis, HBV, HCV infection or other serious infectious diseases; 7. With clinically significant cardiovascular disease: (1) uncontrolled hypertension (systolic blood pressure =150mmHg and/or diastolic blood pressure =90mmHg); (2) A history of myocardial infarction or unstable angina pectoris within 6 months before enrollment; (3) congestive heart failure or grade ? heart failure; (4) Arrhythmias requiring severe medical treatment, excluding asymptomatic atrial fibrillation with controlled heart rate; 8. Had undergone major surgical surgery or would have surgical treatment within 1 month before enrollment, including but not limited to abdominal surgery before disease progression; 9. Use of any blood components or cell growth factors or conduct blood transfusion activities within 14 days before enrollment; 10. Participated in or is participating in other clinical trials within three months; 11. Participants deemed unsuitable by the investigator to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety; | — |
Countries
China
Contacts
Public ContactLiu Mubiao
Zhuhai People's Hospital
Outcome results
None listed