This project aims to create a multi-scale patient-specific human virtual twin for patients eligible for CAR T cell therapy, which can be extended to cellular immunotherapies in general. The virtual twin will be fully integrated into the ecosystem under the Digital Europe Programme and will be available as a research-use-only prototype in relevant application environments with technology readiness level 6. The virtual twin will support decision-making throughout the patient's journey, from diagnosis to pre-treatments, cellular immunotherapy, and late patient monitoring. This will enable patients and health experts to identify the most effective course of therapy.

The virtual twin for cellular immunotherapies will take multi-scale modeling to the next level by providing methodological concepts for integrating "living drugs" such as CAR T cells into the human virtual twin ecosystem.

To achieve this goal, the project builds on existing data models for hematological malignancies and multiple myeloma (MM) to create a virtual twin for CAR T cell therapy for MM patients. The implementation process follows software development principles for software as medical devices, ensuring the exploitation of the research-use-only prototype. Patient's, SSH, gender differences, and other stakeholders' perspectives are fully integrated into the design, specification, and implementation process.

A modular software architecture and extensible ontologies/terminologies are utilized throughout the implementation process, making the reference model easily transferable to other indications that can be treated with CAR T cell therapy or other cellular immunotherapies. Overall, the CERTAINTY virtual twin will provide decision support for patients and health experts, improving the effectiveness of cellular immunotherapies and advancing precision medicine.

Fraunhofer SCAI is developing AI/ML models for patient stratification and for predicting therapy response and adverse reactions. Furthermore, SCAI provides a federated learning platform.

The EU consortium "CERTAINTY – A cellular immunotherapy virtual twin for personalized cancer treatment" is being funded by the European Commission with almost EUR 10 million over the next 4.5 years.