Genetically Modified T Cells Against Ovarian Cancer

Status Recruiting

Clinical Trial Summary

The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).

Clinical Trial Description

Ovarian cancer (OC) is a cancer that forms in or on an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015 OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for OC consists of surgery, chemotherapy, radiotherapy and sometimes, novel immunotherapies. The best treatment options depend on many factors, including the type of OC, its stage and grade, as well as the general health of the patient.

Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. Novel chimeric antigen receptor gene modified T cell (CART) based immunotherapy has demonstrated great successes in B cell malignancies. Here, the study aim is to evaluate the safety and efficacy of genetically engineered OC-specific and immune modulatory T cells in patients. The primary study objectives are to evaluate the safety of the investigational product, autologous OC-IgT cells, to subjects by IV and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous OC-IgT cells in vitro, and (2) to determine the anti-OC efficacy of the OC-IgT cells. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03184753
Study type	Interventional
Source	Shenzhen Geno-Immune Medical Institute
Contact	Lung-Ji Chang, PhD
Phone	86-075586725195
Email	c@szgimi.org
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	May 15, 2017
Completion date	December 31, 2020

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