An expanded access record providing HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes) in Epstein-Barr Virus Infection, Cytomegalovirus Infections and Adenovirus Infection, sponsored by Baylor College of Medicine. Available. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Baylor College of Medicine · Expanded access
This Expanded Access Program (EAP) allows qualified physicians within Texas to obtain access to multivirus-specific cytotoxic T lymphocytes (VSTs) developed under Baylor College of Medicine's TETRAVI program (NCT04013802) for the treatment of persistent or recurrent infections with EBV, CMV, adenovirus, or BK virus in pediatric patients being treated in Texas who have received allogeneic stem cell transplants and have no other suitable therapeutic options.
This EAP is limited to pediatric patients being treated in the State of Texas. In this program, Baylor College of Medicine's Center for Cell and Gene Therapy (CAGT) will provide applicable physicians with copies of a template protocol and consent form, allowing each site to establish its own single-patient expanded access protocol. Baylor will also issue a Letter of Authorization (LOA) to cross-reference its own IND. This LOA will accompany the local site's submission to the FDA. The VSTs will be provided to eligible patients through this mechanism upon IRB and FDA approval of the treating site's individual patient protocol.
The aim is to enable access to off-the-shelf partially HLA-matched virus-specific T cells for pediatric patients located in Texas (USA) with limited treatment options due to persistent or resistant viral infections post-transplant.
175 studies on the registry are indexed under Epstein-Barr Virus Infections; 60 are open to participants now.
Browse Epstein-Barr Virus Infections studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Banked, partially HLA-matched virus-specific T cells (VSTs) directed against EBV, CMV, adenovirus, and BK virus.
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Epstein-Barr Virus Infections →