Chimeric antigen receptor T-cells in New Zealand: challenges and opportunities.

Chimeric antigen receptor (CAR) T-cells are a personalised cell and gene therapy for cancer that are becoming an international standard of care for some refractory B-cell leukaemias, non-Hodgkin lymphomas and myeloma. A single CAR T-cell administration can result in durable complete response for some recipients. Domestic CAR T-cell manufacturing capability was established for Aotearoa New Zealand's first CAR T-cell trial (ENABLE, ClinicalTrials.gov NCT04049513). This article outlines CAR T-cell manufacturing and logistical considerations, with a focus on New Zealand's environment for this personalised cell and gene therapy. We discuss Māori engagement in CAR T-cell trial and clinical service design, and propose enhancing Māori guardianship (kaitiakitanga) over cells and genetic material through on-shore manufacture. Strategies to safely deliver CAR T-cells within New Zealand's healthcare system are outlined. Finally, we discuss challenges to, and opportunities for, widening CAR T-cell availability and assuring equity of access. Based on our experience, we consider Aotearoa New Zealand to be in an excellent position to develop and implement investigational and commercial CAR T-cell therapies in the future.