ovarian cancer
Conditions
Interventions
experimental group:CAR-M
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: [1] Patients or their legal guardians voluntarily participate in and sign the informed consent form; [2] Female patients aged from 18 to 70 years old;[3] Patient ECOG score= 2, Expected survival > 12 weeks;[4] Pathological diagnosis of ovarian cancer, Including epithelial, germline, sex cord stromal tumors and other pathological types; And detected the HER 2 by immunohistochemistry, HER 2 expression level =10%;[5] Received at least first-line treatment after the diagnosis of ovarian cancer, Including disease recurrence / progression during first-line treatment; Definition of recurrence and progression (meeting any of the following conditions): 1) well-documented radiographic progression; 2) Continuous elevation of CA125 (confirmed after 1 week) with clinical symptoms or physical examination indicating disease progression ;[6] Have measurable or evaluable lesions (ascites is necessary), At least one measurable lesion (as per RECIST v1.1, The measurable lesion spiral CT scan has a long diameter = 10mm or a short diameter = 15mm; Lesions treated with previous topical treatment, It can be used as target lesions after clear progression according to RECIST v1.1); [7] Patients with good vital tissue and organ function, Meet the following requirements: patients should have normal myeloid hematopoietic function; The blood routine meets the following standards: ANC=1.5*10^9 / L; PLT=80g/L; HGB=90g / L (no growth factor or blood transfusion support must have been received within 14 days prior to the laboratory test); Blood biochemical tests met the following criteria: TBIL=1.5 times ULN (=3 times ULN in subjects with liver metastasis); ALT / AST=3 times ULN (if liver metastasis, Then ALT / AST=5 times ULN); Serum creatinine was =1.5 times ULN, Creatinine clearance> 50 mL/min/1.73m2 (according to the Cockcroft-Gault formula); Lung function: indoor oxygen saturation =95%; Coagulation met the following criteria: INR <1.5 times ULN, PTAPTT <1.5 times ULN; Cardiac function: left ventricular ejection fraction (LVEF) =40%.;[8] Non-surgical sterilization or reproductive age women need a medically approved contraceptive after informed consent, during study treatment and within 8 weeks after the study treatment period; non-surgical sterilization women of reproductive age must have negative blood HCG examination within 72h before study randomization; and must be non-lactating; [9] Patients can receive G-CSF ascending white needle injection.
Exclusion criteria
Exclusion criteria: [1] Received the following anti-tumor therapy before apheresis blood: 1) received cytotoxic therapy within 14 days; 2) Received investigational medication within 28 days (if the above treatment is both investigational medication, According to the 28-day washout period); 3) Receiving immunomodulator treatment within 7 days; 4) Received targeted therapy within 28 days; [2] Previous CAR-T cell therapy or other cell therapy or therapeutic tumor vaccine targeting any target; [3] Infectious diseases (such as HIV, active hepatitis B or hepatitis C infection, active tuberculosis, etc.); [4] Have a serious underlying disease, For example: 1) there is evidence of severe active virus, bacterial infection, or uncontrolled systemic fungal infection; 2) Active or unstable autoimmune disease, with autoimmune disease within 3 years and may relapse; 3) Dementia or mental state change with obvious clinical evidence; [5] Hyperallergic constitution or a history of severe allergy; [6] combined with heart, lung, brain, liver, kidney and other important organs dysfunction; [7] Previous gastrointestinal perforation, abdominal abscess or recent (within 3 months) intestinal obstruction, imaging findings or clinical symptoms suggesting intestinal obstruction; [8] Have cardiac clinical symptoms or disease that are not well controlled, (1) New York Heart Association (NYHA) Grade 2 heart failure (2) unstable angina (3) myocardial infarction within 1 year (4) atrial fibrillation: clinically significant supraventricular or or ventricular arrhythmia requiring treatment or intervention (5) PR interval> 250ms or QTc> 250ms; [9] Abnormal coagulation function (INR> 2.0 or prothrombin time PT> 16s), Having bleeding tendency or receiving thrombolytic or anticoagulant therapy (allowing prophylactic use of low-dose aspirin, low-METular-weight heparin); [10] Chronic diseases require treatment with systemic corticosteroids or other immunosuppressive agents. Treatment with systemic corticosteroid hormones or other immunosuppressive agents (=30 mg prednisone or an equivalent dose) within 30 days before apheresis blood. Except for the following: treatment with topical, ocular, articular cavity, intranasal and inhaled corticosteroids; short-term corticosteroids (e. g. prevent contrast allergy); [11] Toxeffects of previous anti-tumor therapy have not been restored to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE 5.0) level =1, Except for alopecia or grade 2 peripheral neuropathy; [12] Being diagnosed with or having been treated with other malignancies other than epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer; [13] Pregnant or lactating women, Or women with a pregnancy plan within six months; [14] Doctors believe that there are other reasons for not being included in the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Total remission rate;Complete remission rate;Partial remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival; | — |
Countries
China
Contacts
Public ContactChen Buze
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed