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.
Exclusion Criteria:
Banked, partially HLA-matched virus-specific T cells (VSTs) directed against EBV, CMV, adenovirus, and BK virus.
No study locations are listed for this record.
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Epstein-Barr Virus Infections→
Baylor College of Medicine