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NCT04476251 · ClinicalTrials.gov registry record · Early Phase 1
E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT04476251: Clinical Trial Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT04476251 is a Early Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04476251, a Early Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: More than 12,000 cases of cervical cancer are diagnosed in the United States each year. A new therapy has been developed that involves taking white blood cells from a person, genetically modifying the cells in a lab so they recognize cancer, and then giving the cells back to the person. Researchers want to see if this therapy can help people with cervical cancer. Objective: To find out if people with Stage IIB-IVA cervical cancer can safely be given E7 T-cell receptor (TCR) T cells before they get standard treatment. Eligibility: People age 18 and older who have Stage IIB-IVA cervical cancer Design: Participants will be screened under a separate protocol. Tests will include: * Physical exam * Medicine review * Blood tests * Pregnancy test (if needed) * Vein assessment * Tumor sample or biopsy * Electrocardiogram (to record the hearts electrical activity) * Imaging scans, x-rays, and/or endoscopy * Heart and/or lung tests. Some screening tests will be repeated during the study. Participants will undergo leukapheresis. For this, blood is removed through a needle in the arm. A machine removes the white blood cells. The rest of the blood is returned through a needle in the other arm. Participants may need to have a large catheter inserted into a vein. Participants will stay at the hospital for 2-3 weeks. They will get chemotherapy drugs. They will get the E7 TCR T cells as an intravenous infusion. They will get the drug aldesleukin. Participants will visit the National Institutes of Health (NIH) 3 and 6 weeks after treatment. They will be contacted yearly for 5 years. They will be asked to participate in long-term follow-up for 15 years....
Interventions
- BIOLOGICAL E7 T-Cell Receptor (TCR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2021-09-15 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04476251
The ClinicalTrials.gov registry entry for NCT04476251 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which E7 T-Cell Receptor (TCR) is the first listed.
NCT04476251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04476251 about?
NCT04476251 is a clinical study titled "E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer". Background: More than 12,000 cases of cervical cancer are diagnosed in the United States each year. A new therapy has been developed that involves taking white blood cells from a person, genetically modifying the cells in a lab so they recognize cancer, and then giving the cells back to the person....
What is the current status of trial NCT04476251?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2021-01-14. Estimated completion is 2021-09-15.
What interventions are being tested in trial NCT04476251?
The interventions under investigation include: E7 T-Cell Receptor (TCR) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04476251?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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