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NCT02065362 · ClinicalTrials.gov registry record · Phase 1
TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC
A Phase 1 study of EBV-positive Nasopharyngeal Carcinoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT02065362 is a Phase 1 study of EBV-positive Nasopharyngeal Carcinoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 14 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02065362, a Phase 1 study of EBV-positive Nasopharyngeal Carcinoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study using special immune cells. Most patients with NPC show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC, suggesting that it may play a role in causing the disease. The cancer cells infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to recognize and kill special parts of EBV infected cells can survive in patient's blood and affect the tumor. We already have given EBV-specific cytotoxic T cells to 30 patients with active NPC and have seen anti-tumor activity in 14 of 30 patients. We are now trying to find out if we can improve this treatment. First, we want to give T cells where more of the cells recognize at least two of the four EBV proteins expressed on NPC cells. We call these cells NPC-specific cytotoxic T cells. Second, we found that T cells work better if we add a receptor to the T cells called DNR (Dominant Negative Receptor). DNR makes T cells resistant to TGFbeta, a factor secreted by cancer cells that helps them escape being killed by the immune system. In this study we will therefore place the DNR gene into NPC-specific T cells (DNR.NPC-specific T cells). In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow the T cells we infuse to expand and stay longer in their body, and pot
Conditions Studied
Interventions
- BIOLOGICAL DNR.NPC-specific T cells
- BIOLOGICAL DNR.NPC-specific T cells + cyclophosphamide + fludarabine
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-02 |
| Est. Completion | 2033-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02065362
The ClinicalTrials.gov registry entry for NCT02065362 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with EBV-positive Nasopharyngeal Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which DNR.NPC-specific T cells is the first listed.
NCT02065362 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02065362 about?
NCT02065362 is a clinical study titled "TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC". Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study using special immune cells. Most patients with NPC show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is foun...
What is the current status of trial NCT02065362?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-02. Estimated completion is 2033-02.
What conditions does trial NCT02065362 study?
This clinical trial studies the following conditions: EBV-positive Nasopharyngeal Carcinoma.
What interventions are being tested in trial NCT02065362?
The interventions under investigation include: DNR.NPC-specific T cells (BIOLOGICAL), DNR.NPC-specific T cells + cyclophosphamide + fludarabine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02065362?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02065362 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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