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NCT02379520 · ClinicalTrials.gov registry record · Phase 1
HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA
A Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus Positive Oropharyngeal Carcinoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT02379520 is a Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus Positive Oropharyngeal Carcinoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 32 participants, below the 402-participant average among 7 other Human Papillomavirus-Related Carcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02379520, a Phase 1 study of Human Papillomavirus-Related Carcinoma and Human Papillomavirus Positive Oropharyngeal Carcinoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers. If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.
Conditions Studied
Interventions
- DRUG Fludarabine
- BIOLOGICAL Nivolumab
- DRUG Cytoxan
- GENETIC HPV Specific T Cells
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-09 |
| Est. Completion | 2033-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02379520
The ClinicalTrials.gov registry entry for NCT02379520 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 7 other Human Papillomavirus-Related Carcinoma trials with a reported enrollment target (92% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Human Papillomavirus-Related Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Fludarabine is the first listed.
NCT02379520 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02379520 about?
NCT02379520 is a clinical study titled "HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA". Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cell...
What is the current status of trial NCT02379520?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2015-09. Estimated completion is 2033-10.
What conditions does trial NCT02379520 study?
This clinical trial studies the following conditions: Human Papillomavirus-Related Carcinoma, Human Papillomavirus Positive Oropharyngeal Carcinoma, Human Papillomavirus Positive Cervical Carcinoma, Human Papillomavirus Positive Anal Carcinoma, Human Papillomavirus Positive Vulvar Carcinoma.
What interventions are being tested in trial NCT02379520?
The interventions under investigation include: Fludarabine (DRUG), Nivolumab (BIOLOGICAL), Cytoxan (DRUG), HPV Specific T Cells (GENETIC).
Who is sponsoring clinical trial NCT02379520?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02379520 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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