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NCT02408016 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Terminated
Registry status
Phase 1
Development phase
11
Enrollment target

NCT02408016: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT02408016 is a Phase 1 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02408016, a Phase 1 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
11 participants
Enrollment target

Study Summary

This phase I/II trial studies the side effects and best dose of genetically modified T cells in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms tumor (WT)1 on their surfaces. This study takes a type of immune cell from patients, called T cells, and modifies their genes in the laboratory so that they are programmed to find cells with WT1 and kill them. The T cells are then given back to the patient. Cyclophosphamide and aldesleukin may also stimulate the immune system to attack cancer cells. Giving cyclophosphamide and aldesleukin with laboratory-treated T cells may help the body build an immune response to kill tumor cells.

Primary Outcome

Based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.

Interventions

  • DRUG Cyclophosphamide
  • OTHER Laboratory Biomarker Analysis
  • PROCEDURE Therapeutic Conventional Surgery
  • BIOLOGICAL Aldesleukin
  • BIOLOGICAL Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2015-05-22
Est. Completion 2020-06-30
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

Why NCT02408016 stopped before completion

NCT02408016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT02408016 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02408016 about?

NCT02408016 is a clinical study titled "Genetically Modified T Cells in Treating Patients With Stage III-IV Non-small Cell Lung Cancer or Mesothelioma". This phase I/II trial studies the side effects and best dose of genetically modified T cells in treating patients with stage III-IV non-small cell lung cancer (NSCLC) or mesothelioma. Many types of cancer cells, including NSCLC and mesothelioma, but not most normal cells, have a protein called Wilms...

What is the current status of trial NCT02408016?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2015-05-22. Estimated completion is 2020-06-30.

What interventions are being tested in trial NCT02408016?

The interventions under investigation include: Cyclophosphamide (DRUG), Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Aldesleukin (BIOLOGICAL), Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes (BIOLOGICAL).

Who is sponsoring clinical trial NCT02408016?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02408016's enrollment target sits among peer trials

11 1911th of 2000 higher than 88 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02408016, the US trial registry maintained by the National Library of Medicine. NCT02408016 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.