Phase I Clinical Trials in Adoptive T-Cell Therapies
针对工程化T细胞在肿瘤治疗中的I期剂量探索难题,提出了三种新设计方法,解决了因无法完全给药导致的数据偏差问题,性能优于现有方法。
We develop three approaches to phase I dose finding designs for engineered T cells in oncology. Our goal is to address a very particular difficulty in this clinical setting: an inability to fully administer the dose allocated to some patients. Current designs can be biased as a result of this incomplete information being ignored or discarded from the analysis. The performance of the three proposed solutions is largely similar, and all offer an advantage over the currently used design. One of the three methods is supported by theoretical study, and we provide some new results on this approach.