Phase IIIa Study of RR001 Gene Therapy Combined with Chemotherapy for Locally Advanced Pancreatic Adenocarcinoma

What this Trial Is About

Researchers are investigating a new cell-based gene therapy called RR001 for patients with locally advanced pancreatic ductal adenocarcinoma, a type of pancreatic cancer that is not eligible for surgery. This Phase IIIa open-label, non-randomized clinical trial aims to test the safety and effects of increasing doses of RR001, which uses the patients own genetically modified cells to target cancer cells. The study addresses the need for new treatments to increase the chances of surgery and improve outcomes in this challenging condition. The treatment involves two cycles of chemotherapy using Nab-paclitaxel and gemcitabine given on days 1, 8, and 15 of a 28-day cycle. After completing chemotherapy, participants receive an injection of RR001 directly into the tumor at one of three escalating dose levels. This approach combines chemotherapy with a novel gene therapy delivered locally to the tumor. The trial evaluates the safety and feasibility of producing and administering this personalized cellular product. Participants will be monitored from the time they consent through 26 weeks after RR001 delivery, including regular visits to assess side effects, tumor response, and quality of life. Evaluations consist of clinical exams, imaging scans, laboratory tests, and questionnaires. Researchers will measure safety by tracking adverse events, and efficacy by tumor response, progression, survival, and quality of life scores. The study includes careful ongoing safety monitoring and follow-up to understand how the treatment affects patients over time.

Phase I/IIa Study: RR001 Administered Following Chemotherapy Cycles for Patients With Locally Advanced Pancreatic Carcinoma