Despite the transformative potential of CAR-T cell therapies, their widespread adoption is hindered by significant barriers, including prohibitive costs, severe toxicities, logistical challenges in manufacturing, and limited efficacy. The iN-KEY consortium aims to overcome these challenges by developing and clinically validating a next-generation, “off-the-shelf” immunotherapy platform for the treatment of Multiple Myeloma (MM).
At the heart of this project is a disruptive platform based on engineered induced Pluripotent Stem Cells (iPSCs). This platform integrates several key innovations: 1) Highly immunocompatible, haplo-matched iPSC lines for broad allogeneic use; 2) A proprietary, high-capacity Docking Platform (DoP) for safe, precise, and multiplexed integration of effector genes, eliminating the risks associated with viral vectors; 3) A dual-targeting strategy combining a Chimeric Antigen Receptor (CAR) against BCMA and a Synthetic T-cell Activating Bifunctional (STAb) construct against CD19; and 4) A suite of additional effector genes to enhance cell persistence, homing, and safety.
This therapeutic product will be manufactured using a scalable, automated, and feeder-free GMP process, with quality control enhanced by novel multi-omics and AI-driven methodologies to ensure product consistency and safety. The project will culminate in a first-in-human clinical trial to assess the safety and preliminary efficacy of the therapy in patients with relapsed/refractory Multiple Myeloma. By addressing the core challenges of scalability, safety, accessibility, and cost, the iN-KEY platform has the potential to unlock a new generation of complex, affordable, and highly effective immunotherapies, benefiting patients and healthcare systems across Europe and beyond.
This project is currently in grant preparation with the European Commission.
This project contributes to the UN Sustainable Development Goals (SDGs) 3.
