Standardizing Step-Up Dosing Escalation Protocols to Master Early-Phase Safety and Maximize the Therapeutic Window of T-Cell Engagers
- Implementing evidence-based step-up dosing regimens to reduce the cytokine response, allowing for higher target doses while minimizing the risk of severe CRS and ICANS
- Transitioning to Modified MABEL models that utilize real-time PD markers to identify the optimal biological dose
- Ensuring escalation decisions are based on anti-tumor activity rather than just circulating drug levels