DECODE CRS: Accelerating Immunotherapy Access And De-risking CRS

The clinical potential of CAR-T and T-cell engager (TCE) therapies is severely restricted by Cytokine Release Syndrome (CRS). Heterogeneity across therapies and a lack of standardized protocols create intense monitoring burdens and high development costs, forming a shared clinical barrier across the immunotherapy ecosystem. To solve this challenge, the DECODE CRS Coalition brings together trial sponsors, clinicians, and regulators to generate cross-sector, regulatory-ready evidence that no single organization can achieve alone.

The coalition directly helps clinical trials by establishing consensus on best practices for objective CRS grading, precise data collection guidelines, and adverse event adjudication. Additionally, it is launching a prospective study of over 150 patients to collect a first-in-kind real-world dataset combining wearable data and patient outcomes. By building a validated CRS early warning model and data-driven alerting tools, the coalition provides trial sponsors with broadly applicable evidence standards. Ultimately, this pre-competitive collaboration optimizes clinical trials by reducing adverse event variability, mitigating operational uncertainties, and lowering system-wide development costs to safely expand decentralized, outpatient therapy delivery.