Study of Dual Intravenous and Intraperitoneal TROP2-Directed CAR-NK Cell Therapy Combined with Cetuximab for Advanced Colorectal Cancer Spread to the Peritoneum

What this Trial Is About

Researchers are studying a new treatment approach for patients with colorectal cancer that has spread to the peritoneum, the lining of the abdominal cavity. This trial aims to find the highest safe dose and best schedule for giving a special type of immune cells called NK cells, modified to target cancer cells, both by vein and directly into the abdomen. The study also looks at combining this cell therapy with the drug cetuximab to control the cancer. It is a Phase 12 trial focusing on safety and dosing. Participants will receive NK cells that have been engineered to attack cancer, administered both intravenously through a vein and intraperitoneally directly into the abdominal cavity. Alongside this, they will receive cetuximab via vein. The trial includes two parts a dose escalation phase to find the maximum tolerated dose, followed by a dose expansion phase to study the recommended dose further. Additional drugs like cyclophosphamide and fludarabine are given by vein as part of the treatment process. Throughout the trial, participants will undergo diagnostic laparoscopy and placement of a catheter for intraperitoneal delivery. Blood and peritoneal fluid samples will be collected, and biopsies may be performed. Researchers will monitor safety and adverse events for about one year after treatment. The study is non-randomized, with all participants receiving the experimental treatment, and will continue until November 2030.

Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC Trial")