NCT03362606

Engineered Immune Effectors Against Ovarian Cancer

Intervention of Ovarian Cancer Based on Engineered Immune Effectors (EIEs)

• Status: Unknown
• 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 cytotoxic lymphocytes (OC-CTLs) in women.

Detailed description

Ovarian cancer is a cancer that forms in or on an ovary. The majority of ovarian cancers arise from the epithelium (outer lining) of the ovary. In 2015 it was reported 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 ovarian cancer consists of surgery, chemotherapy, immunotherapy and sometimes, radiotherapy. The kind of treatment depends on many factors, including the type of ovarian cancer, its stage and grade, as well as the general health of the patient. Adoptive immunotherapy with cytotoxic T lymphocytes (CTLs) reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of ovarian cancer specific cytotoxic T lymphocytes in patients.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	OC-CTLs	2 to 4 infusions, once a week, for 1x10\^5\~4x10\^6 CTLs/kg via IV, abdominal cavity or tumor injection each time

Timeline

• Start date: 2017-11-15
• Primary completion: 2019-01-31
• Completion: 2020-12-01
• First posted: 2017-12-05
• Last updated: 2019-09-19

Locations

3 sites across 1 country: China