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NCT03354390 · ClinicalTrials.gov registry record · Phase 1
HERV-E TCR Transduced Autologous T Cells in People With Metastatic Clear Cell Renal Cell Carcinoma
A Phase 1 study of Kidney Cancer, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT03354390: Active Phase 1 study of Kidney Cancer, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT03354390 is a Phase 1 study of Kidney Cancer that is active but no longer recruiting, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 17 participants, below the 880-participant average among 60 other Kidney Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03354390, a Phase 1 study of Kidney Cancer, is active but no longer recruiting, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells. Objective: To see if gene transfer is safe and causes tumors to shrink. Eligibility: People at least 18 years old with certain kidney cancer Design: Participants will be screened with blood and urine tests. They may have: * Scans * Heart, lung, and eye tests * Lab tests * Tumor samples taken Participants will have leukapheresis. Blood will be removed by a needle in an arm. It will go through a machine that removes white blood cells. Plasma and red cells will be returned through a needle in the participant s other arm. Participants cells will be grown in the lab and genetically changed. Participants will stay in the hospital 2-3 weeks. There they will: * Get 2 chemotherapy drugs by catheter (thin plastic tube) inserted into a vein in the chest. * Get the changed cells via catheter. * Get a drug to increase white blood cell count and one to make the cells active. * Recover for about a week. * Have lab and blood tests. After leaving the hospital, participants will: * Take an antibiotic for several months. * Have leukapheresis. * Have one- or two-day clinic visits every few weeks for 2 years, and then as determined by their doctor. These will include blood and lab tests, imaging studies, and physical exam. Participants will have follow-up checks for up to 15 years.
Primary Outcome
Toxicity profile at least possible attributed to treatment regime for each dose level using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 except for hematological toxicities Toxicity profile as measured by using the Common Terminology Criteria for Adverse Events (CTCAE version 5.0) for grade 2 and above. According to https://ctep.cancer.gov/, CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided
Conditions Studied
Interventions
- BIOLOGICAL cell infusion
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-07-20 |
| Est. Completion | 2026-03-03 |
| Phase | Phase 1 |
What the registry record for NCT03354390 still lists
NCT03354390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 880-participant average among 60 other Kidney Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Kidney Cancer appearing as the primary indexed condition, and to 1 intervention - of which cell infusion is the first listed.
NCT03354390 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03354390 about?
NCT03354390 is a clinical study titled "HERV-E TCR Transduced Autologous T Cells in People With Metastatic Clear Cell Renal Cell Carcinoma". Background: Gene transfer is a new cancer therapy takes white blood cells from a person and grows them in a lab. The cells are changed with a virus to attack tumor cells, then returned to the person. Researchers want to see if this therapy fights kidney cancer cells. Objective: To see if gene tra...
What is the current status of trial NCT03354390?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2018-07-20. Estimated completion is 2026-03-03.
What conditions does trial NCT03354390 study?
This clinical trial studies the following conditions: Kidney Cancer.
What interventions are being tested in trial NCT03354390?
The interventions under investigation include: cell infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT03354390?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03354390 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Kidney Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03354390's enrollment target sits among peer trials
17 53rd of 60 higher than 7 of 60 other Kidney Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Kidney Cancer 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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