NCT03351855

HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV

Phase I/II and Multicenter Trial of HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of Human Papilloma Virus (HPV) Infection

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 6 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.

Detailed description

Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16, 18, 31, 45). Around 50-80% of women are infected by HPV within their whole lives. The current treatment of HPV-positive mainly includes drug, cryotherapy, laser, microwave, surgery and so on. Some treatments are convenient, but easy to cause pain or infection and there is still a greater risk of recurrence after treatment. 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 HPV specific cytotoxic T lymphocytes cells in patients.

Conditions

• Human Papilloma Virus

Interventions

Type	Name	Description
BIOLOGICAL	HPV-CTLs	2 to 4 infusions, once a week, for 1x10\^5\~4x10\^6 CTLs/kg by IV each time

Timeline

• Start date: 2017-11-15
• Primary completion: 2019-07-31
• Completion: 2021-12-31
• First posted: 2017-11-24
• Last updated: 2019-09-19

Locations

1 site across 1 country: China