A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer
Start Date
8/8/2024
Completion Date
12/1/2026
Summary
The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV). The main questions aim to answer are: * Is Lenti-HPV-07 safe? * Does Lenti-HPV-07 induce an immune response? Participants will be assigned to a group based on their cancer type * either study drug group A: recurrent and/or metastatic cancer * or study drug group B: newly diagnosed with locally advanced cancer After they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.
Detailed Description
As of 06Nov2025 the recruitment in ARm A of the study (recurrent/metastatic cancers) has been closed to further enrollment, in accordance with the protocol and the study's prespecified operational and/or scientific considerations. No new participants will be enrolled into Arm A, and no additional study drug will be administered within this arm.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Two IM injections Lenti-HPV-07
One IM injection Lenti-HPV-07
Conditions
Locations
Florida Cancer Specialists (from Sarah Canon research Institute)
Orlando, Florida 32827
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma 74146
United States