Intermediate-size IND for Treatment of Patients With Advanced Cancer Using T Cells Engineered to Express TCR Targeting Mutant KRAS

The goal of this intermediate-size expanded access treatment program is to treat a subset of patients with advanced solid cancers, specifically pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), that express KRAS-G12D and the appropriate HLA with adoptive t-cell therapy. Participants will provide leukapheresis product which will be processed and generated in our facility. The participant's peripheral blood T cells will be stimulated and then transduced with GMP-grade retroviral vectors encoding KRAS-G12D-neoantigen reactive TCR. On Days -6 to -4, the participant will receive outpatient chemotherapy as a preparative regimen. On Day 0, participant will receive cell product infusion as an inpatient procedure. Following infusion, participant will receive supportive care through discharge.

NCT Number	NCT07614048
Lead Sponsor	Providence Health & Services
Conditions	PDAC - Pancreatic Ductal Adenocarcinoma, Colorectal Cancer
Updated on ClinicalTrials.gov	2026-07-23