DIME PROJECT

DECODE-CRS: Accelerating safer, scalable immunotherapy

Cytokine release syndrome (CRS) remains one of the greatest barriers to realizing the full potential of targeted immunotherapy. The risk of severe CRS inflates development costs, complicates regulatory approvals, and prevents broader adoption, especially in community settings. This results in limited patient access, slowed innovation, and significant commercial risk for developers.

DECODE-CRS, led by DiMe and Ametris, is the first industry-wide coalition creating the foundation for CRS de-risking products that are clinically appropriate, regulatory-acceptable, and commercially viable.

Contribute to this initiative

Together, this coalition will advance the field through:

A CRS adjudication framework

A framework for grading CRS events to support objective assessment in clinical research, including decision rules and reporting standards for trials and real-world evidence generation.

A clinical and commercial feasibility assessment

A comprehensive assessment of implementing digital health technologies (DHTs) for CRS monitoring, capturing clinical utility, workflow integration, and adoption potential across healthcare settings. This evaluation also addresses reimbursement and regulatory considerations to guide product development and commercialization strategy.

A technology evaluation

An evaluation of candidate digital health technologies aligned with study objectives, usability, and technical performance. Findings will support optimal study design and endpoint validation.

The coalition is currently welcoming individual contributors to shape the future of CRS management by providing their expertise in the areas of adjudication practices, clinical monitoring workflows, and digital health approaches.

Why now

CRS remains one of the most significant clinical barriers to broader access to bispecific antibodies and CAR T-cell therapies, limiting where and how patients can safely receive these treatments. Furthermore, fragmentation in CRS grading and monitoring, treatment approaches, and data collection across trials and real-world care slows innovation, limits learning, and constrains adoption.

No single sponsor can solve this challenge alone. Building on the foundation established by DATAcc by DiMe’s De-risking CRS, the shared evidence generated by this coalition will be clinically meaningful, regulatory-relevant, and applicable across modalities, enabling safer, scalable immunotherapy delivery at an increased pace.

This initiative will rapidly advance into the next phase, focused on generating high-quality, standardized data to support scalable, clinically robust CRS monitoring products. Learn more about the next phase of the project and explore opportunities to get involved.