Actively Recruiting
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Led by Baylor College of Medicine · Updated on 2025-08-08
47
Participants Needed
2
Research Sites
529 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 investigators want to find out if they can use these banked VSTs to fight infections caused by the viruses mentioned above.
CONDITIONS
Official Title
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using bone marrow, peripheral blood stem cells, or single/double cord blood
- Or received CAR-T cells targeting an antigen on virus-specific T cells
- Persistent, increasing, or recurrent infection with CMV, adenovirus, EBV, BK virus, or JC virus despite at least 7 days of standard therapy, or early treatment if unable to tolerate standard therapy
- Clinical status allowing tapering steroids to 0.5 mg/kg/day methylprednisolone or less
- Hemoglobin level of at least 7.0 gm/dl
- Availability of partially HLA-matched multivirus-specific T cells verified by a principal investigator
- Negative pregnancy test if applicable
- Written informed consent or assent provided
You will not qualify if you...
- Receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 28 days before enrollment
- Presence of uncontrolled infections progressing within 72 hours for bacterial or 1 week for fungal infections
- Less than 28 days since allogeneic stem cell transplant or donor lymphocyte infusion or CAR-T treatment
- Active acute graft-versus-host disease grade II to IV
- Uncontrolled relapse of malignancy
- Need for more than 50% oxygen to keep oxygen saturation above 90%
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77003
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
John Craddock, MD
CONTACT
D
Dustin McFadden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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