Principal Scientist Genentech Foster City, California
Adoptive Cell Therapy (ACT) has evolved as one of the most rapidly expanding branches of cancer immunotherapy due to unprecedented clinical successes and regulatory approvals of multiple autologous CD19 and BCMA-targeting Chimeric Antigen Receptor (CAR)-T cell therapies for the treatment of B-cell hematological malignancies. Despite the success, challenges continue to exist for autologous CAR-T therapies including relapse, safety concerns, long ‘vein-to-vein’ time, less flexibility for repeat dosing, high cost and manufacturing hurdles. To address the challenges associated with the autologous CAR-T therapies, ‘off the shelf’ allogeneic cell therapies are under rapid investigation. However, the clinical pharmacology learnings and approaches are evolving as clinical data emerge from early stage development programs. Clinical Pharmacology approaches for allogeneic cell therapies will play a key role in optimizing dose selection, dosing frequency and regimen, optimizing lymphodepleting regimen, and identifying key patient- and product-specific characteristics impacting clinical outcomes. This presentation will cover the current development landscape of allogeneic cell therapies and unique considerations for its development. In addition, key clinical pharmacology learnings from early stage clinical programs including dose-exposure-response relationship, patient- and product-specific factors impacting PK/PD, repeat dose learnings, and impact of different lymphodepletion regimens will also be discussed.
Learning Objectives:
To discuss the current development landscape of allogeneic cell therapies and unique considerations for its development
To highlight key clinical pharmacology learnings from early stage clinical programs of allogeneic cell therapies including dose-exposure and exposure-response relationship
To discuss other critical factors that may impact clinical outcomes such as enhanced lymphodepletion and repeat dosing