RecruitingPhase 1Phase 2NCT06319963

A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer

An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer

Sponsor

Theravectys S.A.

Enrollment

72 participants

Start Date

Aug 8, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an immunotherapy called Lenti-HPV-07 — a gene therapy-based vaccine — in patients with cancers caused by HPV (human papillomavirus), specifically oropharyngeal (throat) or cervical cancer. The treatment is designed to help the immune system recognize and fight HPV-related cancer cells. **You may be eligible if...** - You have been diagnosed with HPV-related invasive cancer of the cervix or oropharynx (throat/tonsil area), confirmed by biopsy - Your general health is good (ECOG 0 or 1) - Your liver, kidneys, lungs, and blood counts are in an acceptable range **You may NOT be eligible if...** - You are HIV positive - You have active hepatitis B or hepatitis C infection - You have other conditions that would make this immunotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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