Phase III Study of Intravenous HPV-Specific Immune Lymphocytes for Treating HPV Infection

What this Trial Is About

Human papilloma viruses HPV, especially high-risk types like HPV 16, 18, 31, and 45, are linked to cervical cancer and infect a large portion of women during their lives. Current treatments such as drugs, cryotherapy, laser, microwave, and surgery can be painful, risk infection, and have a high chance of recurrence. Researchers are studying the safety and effects of intravenous infusions of HPV-specific cytotoxic T lymphocytes HPV-CTLs as a new treatment approach in this Phase III trial. Participants receive 2 to 4 infusions of autologous or allogenic HPV-specific cytotoxic lymphocytes once a week. Each infusion delivers between 1x105 and 4x106 CTLs per kilogram of body weight intravenously. This study focuses on evaluating the safety and efficacy of these immune cells in treating HPV infection. During the trial, participants will be monitored for adverse events using standard criteria over 6 months. Researchers will also measure viral load responses and overall treatment responses up to one year. Assessments include laboratory tests, biopsies, and clinical evaluations to track the effect of the infusions and participant safety. The total study duration extends through to the end of 2030, with continuous follow-up to evaluate outcomes.

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