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NCT04013802 · ClinicalTrials.gov registry record · Phase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
A Phase 1 study of Viral Infection, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT04013802: Recruiting Phase 1 study of Viral Infection, sponsored by Baylor College of Medicine.
NCT04013802 is a Phase 1 study of Viral Infection that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 47 participants, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04013802, a Phase 1 study of Viral Infection, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have received a product that depletes virus specific T cells. The patient must have had a myeloablative or non-myeloablative allogeneic HSCT using either bone marrow, single/double umbilical cord blood, or peripheral blood stem cells (PBSC) or CAR T cell product targeting an antigen expressed on virus specific T cells. After a transplant, while the immune system grows back, the patient is at risk for infection. Some viruses can stay in the body for life and are normally controlled by a healthy immune system, but if the immune system is weakened, like after a transplant, they can cause life threatening infections. He/she must have had an infection with one or more of the following viruses -Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus (AdV), Human polyomavirus type I (BKV), and human polyomavirus type II (JCV)- that has persisted or recurred despite standard therapy. In this study, the investigators want to use white blood cells that have been trained to treat viral infections. In an earlier study the investigators showed that treatment with such specially trained T cells has been successful when the cells are made from the transplant donor. However as it takes 1-2 months to make the cells, that approach is not practical for patients who already have an infection. In a subsequent study, the investigators were able to create multivirus-specific T cells (VSTs) from the blood of healthy donors and created a bank of these cells. The investigators then successfully used these banked cells to treat virus infections after a stem cell transplant. In this study the investigators have further modified their production method to decrease the potential side effects and the
Primary Outcome
The primary objective is to measure the safety of MVSTs based on patients with grades 3-5 non-hematologic adverse events that are at least possibly related to the T cell product.
Conditions Studied
Interventions
- BIOLOGICAL HLA-matched VSTs
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2031-05-01 |
| Phase | Phase 1 |
What NCT04013802 shows while recruiting
NCT04013802 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Viral Infection appearing as the primary indexed condition, and to 1 intervention - of which HLA-matched VSTs is the first listed.
NCT04013802 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04013802 about?
NCT04013802 is a clinical study titled "TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.". The purpose of this study is to use VSTs (virus-specific T cells) from a donor that is a partial HLA (human leukocyte antigen) match with the patient to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). These cells may also have value in CAR-T recipients who have ...
What is the current status of trial NCT04013802?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2021-03-08. Estimated completion is 2031-05-01.
What conditions does trial NCT04013802 study?
This clinical trial studies the following conditions: Viral Infection.
What interventions are being tested in trial NCT04013802?
The interventions under investigation include: HLA-matched VSTs (BIOLOGICAL).
Who is sponsoring clinical trial NCT04013802?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04013802 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Viral Infection
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 NCT04013802's enrollment target sits among peer trials
47 8th of 11 higher than 4 of 11 other Viral Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Viral Infection 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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Donor-Derived Viral Specific T-cells (VSTs)
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Third Party Viral Specific T-cells (VSTs)
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Trial of Scheduled Versus Treatment Administration of Donor-Derived Viral Specific T-cells for Viral Infections After Stem Cell Transplant
RECRUITING · Phase 2
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