IQ Perspective on Clin Pharm & Pharmacometric Aspects of Development of CAR-T & TCR-T Cellular Tx
Presented by the IQ Novel Modalities Working Group
Sponsored by IQ Translational and ADME Sciences Leadership Group (TALG) & IQ Clinical Pharmacology Leadership Group (CPLG)
With the promise of potentially “single dose curative” paradigm, CAR-T therapies have brought a paradigm shift in the treatment and management of oncology indications specially in hematologic malignancies, and the field is rapidly evolving. For hematologic malignancies US FDA approved CAR-Ts now extend beyond CD-19 targeting CAR-Ts to also include the recently approved BCMA targeting CAR-T. Rapid advancements in the field now include “off-the shelf” allogenic CAR-T therapies in clinical development that overcome the long and difficult wait time seen with autologous CAR-T therapies for cancer patients. There are unique clinical pharmacology, pharmacometric, & biopharmaceutic aspects of development of CAR-Ts that offer challenges yet great opportunity for optimization of development for this important class of ex-vivo gene therapy. This webinar will highlight some of these aspects including characterization of CAR-T dose-exposure-response relationships for efficacy & safety & factors affecting these relationships, FIH dose selection & optimal clinical study design considerations as well as unique aspects of development of TCR-T therapies that offer great potential for solid tumor indications.
- Vijay Upreti, Amgen
- Dale Miles, Genentech/Roche
- Hardik Mody, Janssen