An Early Phase 1 interventional study of anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer, sponsored by Allife Medical Science and Technology Co., Ltd.. Status unknown. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-31.
Sponsored by Allife Medical Science and Technology Co., Ltd. · Early Phase 1, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Allife Medical Science and Technology Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Total dose of 0.5-3 million /kg cells will be administered at day0
Biological: anti-Mesothelin Car NK Cells
anti-Mesothelin Car NK Cells injection
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
Time frame: Day 3-Year 2 after injection
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Allife Medical Science and Technology Co., Ltd.