NCT03362619

Engineered Immune Effectors Against Cervical Cancer

Innovative Treatment of Cervical Cancer Using Engineered Antigen-specific 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

The primary objective of this study is to evaluate the safety of cervical cancer specific engineered immune effectors (CC-EIEs). The secondary objectives are to evaluate the rate of successful CC-EIE generation in vitro and determine the anti-CC efficacy.

Detailed description

Cervical cancer (CC) is a cancer arising from the cervix. Human papillomavirus (HPV) infection causes more than 90% of the cases. Other risk factors include smoking, a weak immune system, birth control pills, starting sex at a young age, and having many sexual partners, but these are less important. Worldwide, CC is both the fourth-most common cause of cancer and the fourth-most common cause of death from cancer in women. The treatment of CC consists of surgical intervention, radiation, chemotherapy and immunotherapy. Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific viral antigens has proven to be effective. Here, the investigators aim to evaluate the safety and efficacy of multiple infusions of CC-specific engineered immune effectors including cytotoxic T lymphocytes in patients.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CC-EIEs	2 to 4 infusions, once a week, for 1x10\^5\~1x10\^7 CTLs/kg via IV, abdominal cavity or intratumoral 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