Phase 2 Study of GT101 Injection Versus Gemcitabine in Women With Recurrent or Metastatic Cervical Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Autologous Tumor Infiltrating Lymphocytes GT101 injection compared with Gemcitabine in women with recurrent or metastatic cervical cancer. This Phase II study is conducted at multiple centers and involves random assignment to one of two treatment groups. It aims to provide important information about these treatments for patients who have already received prior systemic therapy for this cancer. Participants will receive either GT101 injection, a biological treatment derived from the patients own tumor cells, or Gemcitabine injection, a chemotherapy drug. The study is open-label, meaning both the participants and researchers know which treatment is given. Treatments are administered according to the study protocol and monitored for effects over time. During the study, women will undergo regular assessments to evaluate disease progression, treatment response, and safety. This includes imaging scans measured by RECIST 1.1 criteria and monitoring for side effects using standardized criteria. The main outcome measured is progression-free survival over three years, along with duration of response and treatment-related adverse events. Participants will be followed for up to three years to track these outcomes.

Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer