Phase 1 Study of Patient-Derived T Cells Targeting KRAS G12V Mutation in Adults with Advanced Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating a new treatment using specially modified T cells called FHA11KRASG12V-TCR in patients with metastatic solid tumor cancers that have the KRAS G12V mutation. This phase I trial focuses on finding the best dose and understanding the side effects of these autologous patient-derived T cells engineered to recognize and attack tumor cells with this mutation. Participants undergo leukapheresis to collect their T cells, then receive lymphodepletion chemotherapy with drugs such as cyclophosphamide and fludarabine or bendamustine before getting the engineered T cells through an intravenous infusion on day 0. A second infusion may be given between 28 days to one year after the first. Various imaging tests like echocardiography, CT, PET, or MRI scans, along with blood samples and tumor biopsies, are performed at baseline and throughout the trial. During the study, participants are closely monitored for side effects, tumor response, and changes in the tumor environment. Follow-up visits occur on multiple days up to one year after the first infusion, with long-term monitoring extending up to 15 years. The study measures safety outcomes such as adverse events and dose-limiting toxicities, as well as effectiveness outcomes like overall response and survival rates.

Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Solid Tumor Cancers With KRAS G12V Mutations