NCT03393962

Intervention of Ovarian Cancer With Antigen-specific Engineered Immune Effectors

Interventional Treatment of Ovarian Cancer With Cancer Antigen-specific Engineered Immune Effector T Lymphocytes (OC-EIEs)

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: Female
• Age: 10 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, phase I/II trial to evaluate the safety and efficacy of ovarian cancer-specific, engineered immune effectors (OC-EIEs) in women.

Detailed description

Ovarian cancer (OC) is a cancer that is derived from 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, OC is the seventh-most common cancer and the eighth-most common cause of cancer death. Treatment for OC consists of surgery, chemotherapy, immunotherapy and radiotherapy. The kind of treatment depends 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 (CTLs) reactive with tumor antigens has proven to be effective against many types of cancer. OC has been shown to be highly immunogenic and therefore may respond well to innovative antigen-specific immunotherapy. Here, through cancer antigen screening and careful target antigen evaluation, the investigation aims to evaluate the safety and efficacy of multiple infusions of OC antigen-specific, engineered immune effectors (EIEs) in patients with OC.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	OC-EIEs	2 to 4 infusions, once a week, 0.1\~4x10\^6 CTLs/kg; injection via IV, abdominal cavity or intrastumoral.

Timeline

• Start date: 2017-12-01
• Primary completion: 2020-01-01
• Completion: 2020-12-01
• First posted: 2018-01-09
• Last updated: 2018-07-31

Locations

3 sites across 1 country: China