Overview of dose-finding designs and trials in cell and gene therapies

This manuscript provides an overview of recent and relevant dose-finding designs for cell and gene therapies (CGT). We start with an introduction of dose-finding. We then provide a brief overview of CGT, what dose‑escalation designs have already been developed to determine the maximum tolerated dose (MTD) and the optimal biological dose (OBD), and what dose‑escalation designs have been used so far in CGT approvals. We then discuss dose-finding design considerations and challenges for dose-finding for CGT.