This is an open-label, multi-centre, single-arm Phase 1/2 clinical trial of the safety, expansion, persistence and clinical activity of a set of engineered autologous T cells products each capable of recognizing a specific combination mutated KRAS and HLA, activating the T cells and exerting anti- tumour activity in patients with metastatic or locally advanced PDAC.
Adult patient (18 years or older) with newly diagnosed metastatic PDAC or locally advance PDAC disease.
HLA genotyping confirmed with a high-resolution method.
Confirmed KRAS G12V or KRAS G12D mutation in tumour using biopsy sample.
Fertile male and female patients must use a highly effective contraceptive method before, during, and for at least 6 months after the last mutKRAS TCR infusion. Acceptable contraception for women includes implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), sexual abstinence, or a partner who has been vasectomized for at least 6 months. Acceptable contraception for male includes having had a vasectomy for at least 6 months, sexual abstinence, to condoms plus spermicide. Fertile female and male patients must adhere to any treatment-specific pregnancy prevention guidelines for cyclophosphamide (refer to SmPC).
Another malignancy other than PDAC.
Current or history of brain metastasis.
Patient with known genetic status for whom other treatments are available e.g. BRCA, MSI-H.