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This is a single centre、single arm、open-label,to investigate the safety and efficacy of anti-Mesothelin Car NK Cells With Epithelial ovarian cancer
Ovarian cancer ranks second in gynecologic malignancies, but mortality ranks first. It is one of the most serious malignant tumors that threaten women's lives. It is urgent to explore new treatment methods, such as introduction. Tumor immunotherapy strategies to improve treatment outcomes and patient quality of life. Car is a group of fusion proteins composed of multiple parts, including antigen recognition region, transmembrane region, and NK cell stimulation region. NK cells are naive immune cells that are not restricted by MHI and can be activated without additional co-stimulatory regions. After activation, granulin-B and γ-interferon are released, thereby inducing apoptosis of tumor cells and lysis of tumor cells. The study will follow a 3 + 3 design of dose- escalating cohorts. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclearcells which will be sent to a manufacturing site to produce anti-Mesothelin Car NK cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient. Treated patients will undergo serial measurements of safety, tolerability and response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-Mesothelin Car NK Cells | Experimental | Total dose of 0.5-3 million /kg cells will be administered at day0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-Mesothelin Car NK Cells | Biological | anti-Mesothelin Car NK Cells injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment related adverse events as assessed by CTCAE v4.0 | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events that are possibly, likely, or definitely related to study treatment | Day 3-Year 2 after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D010051 |
| Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |