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Recruiting Clinical Trials

Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma

By April 24, 2017No Comments

Condition

Advanced Pleural Malignant Mesothelioma|HLA-A*0201 Positive Cells Present|Recurrent Non-Small Cell Lung Carcinoma|Recurrent Pleural Malignant Mesothelioma|Stage III Non-Small Cell Lung Cancer|Stage III Pleural Mesothelioma|Stage IIIA Non-Small Cell Lung Cancer|Stage IIIB Non-Small Cell Lung Cancer|Stage IV Non-Small Cell Lung Cancer|Stage IV Pleural Mesothelioma

Estimated Enrollment: 20

Age Group: 18 Years and older   (Adult, Senior)

Gender: All

Study Type: Interventional

Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment

Study ID Numbers: 2727.00|NCI-2015-00329|2727|P30CA015704

Study First Received: March 31, 2015

Last Updated: January 4, 2017

Estimated Primary Completion Date: June 2017

 

Primary Outcome Measures:

Evidence and nature of toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0|Feasibility of naive T cell (TN) and central memory T cell (TCM) subsets, measured as the proportion of patients for which T cells are successfully generated and infused and whether only TN or TCM could be generated|Persistence of transduced T cells|Frequency of transferred T cells at biopsied tumor sites between the Tn and Tcm groups|Functional capacity of transferred cells, measured by production of intracellular cytokines|TTP based on RECIST criteria and immune-related response criteria

Sponsors and Collaborators:

Fred Hutchinson Cancer Research Center|National Cancer Institute (NCI)

Website Link: https://ClinicalTrials.gov/show/NCT02408016

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