NCT05895370

HPV-T in HPV-16 Positive Recurrent or Metastatic Solid Tumors

A Phase 1 Study to Assess the Feasibility and Safety of Tumor HPV-E6/E7-Targeting T Cell Suspension for Intravenous Infusion (HPV-T) in Patients With HPV-16 Positive Recurrent or Metastatic Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: BGI, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this protocol is to evaluate the feasibility and safety of HPV-T in HPV 16 positive recurrent or metastatic solid tumor patients.

Detailed description

In this study, HPV-T cells will be cultured from mononuclear cells collected from participant's peripheral blood in the laboratory and they will be given back to the participant intravenously. The use of HPV-T cells involves a combination of IL-2, which is a drug used to help the body's response to treatment on the immune system. A medium dose regimen of IL-2 will be given after the participant receives the infusion of the T-cells. Each HPV-T cell reinfusion is a treatment cycle, and each participant will receive a maximum of four cycles of HPV-T treatment. Whether the participant receives the next cycle of treatment depends on the efficacy of the previous HPV-T treatment, which is assessed by imaging.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	HPV-T	Participant will receive HPV-T iv on day 0. One time of cell infusion constitute a cycle, each participant receives up to four cycles of treatment
DRUG	Interleukin-2	500,000IU/m\^2 SC, after each cell infusion, IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.

Timeline

• Start date: 2023-04-13
• Primary completion: 2024-12-13
• Completion: 2025-04-13
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: China