Evaluating GT307 Tumor-Infiltrating Lymphocyte Treatment in Adults With Ovarian Cancer Who Have Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte therapy called GT307 in patients with solid tumors who have ovarian cancer that has progressed after recurrence or first-line chemotherapy. This single-arm, open design study also assesses pharmacokinetics and efficacy to find the optimal biological dose. The study is sponsored by Grit Biotechnology and focuses on adults aged 18 to 70 years with good overall health and expected survival of at least 12 weeks. Participants will receive injections of GT307 to treat their solid tumors. The study does not include a comparison group and monitors patients over time to evaluate how the treatment is tolerated and its effects on tumor response. Treatment involves tumor sampling, and patients must have measurable lesions as defined by RECIST v1.1. The study will collect data on adverse events and tumor response over a 3-year period. During the study, participants will undergo regular assessments including imaging to confirm disease progression before treatment and to monitor tumor response. Safety will be tracked using the Common Terminology Criteria for Adverse Events CTCAE version 5.0. Researchers will evaluate the objective response rate to treatment over three years. Participants will be monitored closely for side effects and overall health throughout the study period, which begins after enrollment and continues for up to three years.

Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours