Actively Recruiting
Administration of Most Closely HLA-matched Multivirus-specific Cytotoxic T-Lymphocytes for the Treatment of EBV, CMV, Adenovirus, and BK Virus Infections Post Allogeneic Stem Cell Transplant
Led by Baylor College of Medicine · Updated on 2025-08-08
47
Participants Needed
2
Research Sites
260 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
This research aims to study the use of virus-specific T cells (VSTs) derived from donors who are partially matched by human leukocyte antigen (HLA) to treat viral infections after an allogeneic hematopoietic stem cell transplant (HSCT). It also includes patients who received CAR-T cell products that deplete virus-specific T cells. The study focuses on infections caused by Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus, BK virus, and JC virus that persist or recur despite standard treatments. The rationale is to address life-threatening viral infections that occur post-transplant due to a weakened immune system. Participants will receive intravenous infusions of thawed banked VSTs matched as closely as possible by HLA. The initial dose is based on body surface area, with possible doses of 2 x 10^7 or 4 x 10^7 cells. If infection persists, additional infusions may be given, either from the same or a different donor, spaced at least 14 days apart. Before infusion, patients may be given medications to reduce allergic reactions and will be observed for at least one hour afterward. Throughout the study, patients will be monitored weekly for six weeks with clinic visits and blood samples to assess viral levels and immune response. Follow-up continues for approximately one year after the last VST dose. Safety is closely tracked, including treatment-related adverse events and effects on graft-versus-host disease. Blood samples may also be stored for future research while protecting patient confidentiality.
CONDITIONS
Brief 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 standard therapy or early treatment if unable to tolerate standard therapy
- Ability to taper steroids to 0.5 mg/kg/day methylprednisolone or less
- Hemoglobin level of 7.0 gm/dl or higher
- Available virus-specific T cells must be partially HLA matched and verified
- Negative pregnancy test for females of childbearing potential with reduced intensity conditioning
- Provided written informed consent or assent
You will not qualify if you...
- Use of ATG, Campath, or other immunosuppressive T cell antibodies within 28 days before enrollment
- Uncontrolled infections other than the target viruses; bacterial infections must have stable treatment for 72 hours and fungal infections for 1 week without progression
- Less than 28 days since allogeneic stem cell transplant, donor lymphocyte infusion, or CAR-T therapy
- Active acute graft-versus-host disease grade II-IV
- Uncontrolled relapse of malignancy
- Requirement for more than 50% oxygen to maintain saturation over 90%, except if oxygen need is due to the target virus infection
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Varies depending on number of infusions, with doses at least 14 days apart
Participants receive an infusion of partially HLA-matched multivirus-specific cytotoxic T-lymphocytes (VSTs) to treat viral infections after stem cell transplant. Additional doses may be given every 14 days or more apart if needed, based on clinical response and agreement with the medical team.
1 infusion visit plus additional infusion visits every 14 days or more if needed, each followed by at least 1 hour observation
Duration - 6 weeks after the last infusion
Participants are monitored weekly in the clinic for 6 weeks after their last VST infusion to assess treatment response and safety. Blood samples may be collected before infusion and at weeks 1, 2, 4, and 6 for research purposes, with possible additional samples depending on response.
Weekly visits for 6 weeks
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
D
Dustin McFadden
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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