NCT03692637

Study of Anti-Mesothelin Car NK Cells in Epithelial Ovarian Cancer

Clinical Study on the Safety and Efficacy of Anti-Mesothelin Car NK Cells With Epithelial Ovarian Cancer

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Allife Medical Science and Technology Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Epithelial Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	anti-Mesothelin Car NK Cells	anti-Mesothelin Car NK Cells injection

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2018-10-02
• Last updated: 2019-01-31