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Phase I clinical trials in adoptive T-cell therapies.

ABSTRACT: 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.

SUBMITTER: Devlin SM

PROVIDER: S-EPMC9400039 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature

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Phase I clinical trials in adoptive T-cell therapies.

Devlin Sean M SM Iasonos Alexia A O'Quigley John J

Journal of the Royal Statistical Society. Series C, Applied statistics 20210329 4

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 ...[more]

PMID: 36017232

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