Testing The CAR Risk Mitigation In Autologous CAR-T Therapy Clinical Trials In Oncology

By Dr. Kim Strydom, Medical Director, CAGT COE, IQVIA; Dr. Lara Kristina Donato, Medical Director, IQVIA Biotech; and Dr. Edwin Gumafelix, Medical Director, IQVIA

The field of Cell and Gene Therapy (CAGT) has witnessed a consistent rise in activity, driven by ongoing refinements in techniques and the establishment of standardized practices for patient selection and monitoring.

In this white paper, authors expand upon the initial publication in the CAGT Hot Buttons series titled “Starting the CAR: An Introduction to Autologous CAR-T Therapy.” The authors also delve into commonly encountered medical risks associated with the prevalent autologous Chimeric Antigen Receptor T-cell (CAR-T) therapies among patients with B-cell hematologic malignancies. These complications are cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, cardiovascular toxicity, tumor lysis syndrome, infections, hypogammaglobulinemia, and cytopenia.

Developed from a clinical trial perspective, consider the practices outlined in this whitepaper when managing these toxicities.