The “Master Protocol of TCR-modified T Cell Therapy Targeting HLA-restricted KRAS Antigen” (NCT07145450) is a multicentre, open-label Phase 1/2 trial of autologous, gene-modified TCR-T cell therapy (ANOC-001 / ANOC-002 targeting KRAS G12V; ANOC-003 targeting KRAS G12D) in adult patients with metastatic or locally advanced pancreatic ductal adenocarcinoma. The primary objective is to assess safety, persistence, expansion, and preliminary antitumor activity of the infused T cells. Eligible participants must have confirmed PDAC with KRAS G12V or G12D mutation and compatible HLA genotype, measurable disease per RECIST 1.1, and prior standard-of-care first-line therapy. After lymphodepletion with cyclophosphamide and fludarabine, patients receive a single IV infusion of TCR-T cells (non-randomized, single-arm design). Secondary endpoints include T cell persistence and expansion, as well as clinical response and disease stabilization.
This trial evaluates a novel therapy for people with pancreatic cancer whose tumor harbors a specific KRAS mutation. Personalized T cells are engineered from the patient’s own immune cells to recognize and kill cancer cells. After preparatory lymphodepleting chemotherapy, participants receive a single infusion of these T cells. The study aims to evaluate whether this treatment is safe and can shrink or control the tumor. It enrolls adult patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have a confirmed KRAS mutation and compatible HLA type.
