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Phase I clinical trials in adoptive T‐cell therapies

Author

Listed:
  • Sean M. Devlin
  • Alexia Iasonos
  • John O’Quigley

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.

Suggested Citation

  • Sean M. Devlin & Alexia Iasonos & John O’Quigley, 2021. "Phase I clinical trials in adoptive T‐cell therapies," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 70(4), pages 815-834, August.
    • Handle: RePEc:bla:jorssc:v:70:y:2021:i:4:p:815-834
    DOI: 10.1111/rssc.12485
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    References listed on IDEAS

    as
    1. M. Clertant & J. O’Quigley, 2017. "Semiparametric dose finding methods," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 79(5), pages 1487-1508, November.
    2. Nolan A. Wages & Mark R. Conaway & John O'Quigley, 2011. "Continual Reassessment Method for Partial Ordering," Biometrics, The International Biometric Society, vol. 67(4), pages 1555-1563, December.
    3. Xuelin Huang & Swati Biswas & Yasuhiro Oki & Jean-Pierre Issa & Donald A. Berry, 2007. "A Parallel Phase I/II Clinical Trial Design for Combination Therapies," Biometrics, The International Biometric Society, vol. 63(2), pages 429-436, June.
    4. John O'Quigley & Michael D. Hughes & Terry Fenton, 2001. "Dose-Finding Designs for HIV Studies," Biometrics, The International Biometric Society, vol. 57(4), pages 1018-1029, December.
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