Literature DB >> 36017232

Phase I clinical trials in adoptive T-cell therapies.

Sean M Devlin1, Alexia Iasonos1, John O'Quigley2.   

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.

Entities:  

Year:  2021        PMID: 36017232      PMCID: PMC9400039          DOI: 10.1111/rssc.12485

Source DB:  PubMed          Journal:  J R Stat Soc Ser C Appl Stat        ISSN: 0035-9254            Impact factor:   1.680


  21 in total

1.  Adaptive dose insertion in early phase clinical trials.

Authors:  Bo Hu; B Nebiyou Bekele; Yuan Ji
Journal:  Clin Trials       Date:  2010-09-06       Impact factor: 2.486

2.  Integrating the escalation and dose expansion studies into a unified Phase I clinical trial.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  Contemp Clin Trials       Date:  2016-07-05       Impact factor: 2.226

3.  Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma.

Authors:  Stephen J Schuster; Michael R Bishop; Constantine S Tam; Edmund K Waller; Peter Borchmann; Joseph P McGuirk; Ulrich Jäger; Samantha Jaglowski; Charalambos Andreadis; Jason R Westin; Isabelle Fleury; Veronika Bachanova; S Ronan Foley; P Joy Ho; Stephan Mielke; John M Magenau; Harald Holte; Serafino Pantano; Lida B Pacaud; Rakesh Awasthi; Jufen Chu; Özlem Anak; Gilles Salles; Richard T Maziarz
Journal:  N Engl J Med       Date:  2018-12-01       Impact factor: 91.245

4.  A parallel phase I/II clinical trial design for combination therapies.

Authors:  Xuelin Huang; Swati Biswas; Yasuhiro Oki; Jean-Pierre Issa; Donald A Berry
Journal:  Biometrics       Date:  2007-06       Impact factor: 2.571

5.  Adaptive dose-finding based on safety and feasibility in early-phase clinical trials of adoptive cell immunotherapy.

Authors:  Nolan A Wages; Camilo E Fadul
Journal:  Clin Trials       Date:  2019-12-19       Impact factor: 2.486

Review 6.  CD19-targeted CAR T-cell therapeutics for hematologic malignancies: interpreting clinical outcomes to date.

Authors:  Jae H Park; Mark B Geyer; Renier J Brentjens
Journal:  Blood       Date:  2016-05-20       Impact factor: 22.113

7.  Continual reassessment method for partial ordering.

Authors:  Nolan A Wages; Mark R Conaway; John O'Quigley
Journal:  Biometrics       Date:  2011-03-01       Impact factor: 2.571

8.  Sequential monitoring of Phase I dose expansion cohorts.

Authors:  Alexia Iasonos; John O'Quigley
Journal:  Stat Med       Date:  2016-02-07       Impact factor: 2.373

Review 9.  An introduction to chimeric antigen receptor (CAR) T-cell immunotherapy for human cancer.

Authors:  Steven Feins; Weimin Kong; Erik F Williams; Michael C Milone; Joseph A Fraietta
Journal:  Am J Hematol       Date:  2019-02-18       Impact factor: 10.047

10.  Model calibration in the continual reassessment method.

Authors:  Shing M Lee
Journal:  Clin Trials       Date:  2009-06       Impact factor: 2.486

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