Six Dosing and Safety Considerations in the Era of Emerging Therapies

Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies.

Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies include:

Using dose-finding trial designs with the goal of establishing a biologically effective dose, especially when toxicity is not expected to be limiting

Using pharmacokinetic or pharmacodynamic endpoints from preclinical models to predict a range of biologically active doses and inform dosing schedules

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