Basket vs. Umbrella Clinical Trials: Which Precision Oncology Trial Design Is Better?

Cell and gene therapies are beginning to expand into rare oncology applications beyond hematologic malignancies, with recent advances in TIL therapy, TCR-engineered T cells, and early CAR-T studies highlighting both the promise of precision cellular immunotherapy and the development challenges of small patient populations, biomarker-defined eligibility, specialized manufacturing, and confirmatory evidence generation.

High-concentration biologics are pushing subcutaneous delivery beyond a formulation-only challenge, requiring earlier integration of viscosity control, device strategy, injection performance, patient comfort, and manufacturability.