By Yan Leyfman, MD – Cancer Network –
Chimeric antigen receptor (CAR) T-cell therapy has fundamentally reshaped the treatment paradigm for hematologic malignancies, delivering durable remissions in diseases once defined by therapeutic resistance.¹ Yet, despite this success, the field remains constrained by the structural limitations of its own manufacturing paradigm. Current CAR T-cell platforms depend on ex vivo engineering—leukapheresis, genetic modification, expansion, and reinfusion—a process that is not only logistically complex but biologically restrictive. Time to treatment remains a critical vulnerability in aggressive malignancies, while variability in T-cell fitness across patients introduces inconsistency in product quality and therapeutic response. These constraints are not peripheral; they define the outer limits of scalability, accessibility, and ultimately impact.
