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NCT02858310 · ClinicalTrials.gov registry record · Phase 1
E7 TCR T Cells for Human Papillomavirus-Associated Cancers
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 224
- Enrollment target
NCT02858310: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02858310 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 224 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (273% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02858310, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 224 participants
- Enrollment target
Study Summary
Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have an HPV protein called E7 inside of their cells. In this new therapy, researchers take a person's blood, remove certain white blood cells, and insert genes that make them to target cancer cells that have the E7 protein. The genetically changed cells, called E7 T cell receptor (TCR) cells, are then given back to the person to fight the cancer. Researchers want to see if this can help people. Objective: To determine a safe dose and efficacy of E7 TCR cells and whether these cells can help patients. Eligibility: Adults ages 18 and older with an HPV-16-associated cancer, including cervical, vulvar, vaginal, penile, anal, or oropharyngeal. Design: Participants will list all their medicines. Participants will have many screening tests, including imaging procedures, heart and lung tests, and lab tests. They will have a large catheter inserted into a vein. Participants will have leukapheresis. Blood will be removed through a needle in the arm. A machine separates the white blood cells. The rest of the blood is returned through a needle in the other arm. The cells will be changed in the lab. Participants will stay in the hospital. Over several days, they will get: Chemotherapy drugs E7 TCR cells Shots or injections to stimulate the cells Participants will be monitored in the hospital up to 12 days. They will get support medicine and have blood and lab tests. Participants will have a clinic visit about 40 days after cell infusion. They will have a physical exam, blood work, scans, and maybe x-rays. Participants will have many follow-up visits with the same procedures. At some visits, they may undergo leukapheresis. Participants will be followed for 15 years.
Primary Outcome
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- DIAGNOSTIC_TEST EKG
- BIOLOGICAL E7 TCR cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2017-01-27 |
| Est. Completion | 2025-07-02 |
| Phase | Phase 1 |
What the finished NCT02858310 record still lists
NCT02858310 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (273% higher).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02858310 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02858310 about?
NCT02858310 is a clinical study titled "E7 TCR T Cells for Human Papillomavirus-Associated Cancers". Background: Human papillomavirus (HPV) can cause cervical, throat, anal, and genital cancers. Cancers caused by HPV have an HPV protein called E7 inside of their cells. In this new therapy, researchers take a person's blood, remove certain white blood cells, and insert genes that make them to targe...
What is the current status of trial NCT02858310?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 224 participants. The study started on 2017-01-27. Estimated completion is 2025-07-02.
What interventions are being tested in trial NCT02858310?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), EKG (DIAGNOSTIC_TEST), E7 TCR cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02858310?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02858310's enrollment target sits among peer trials
224 227th of 2000 higher than 1,773 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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