AVAILABLENot Applicable

TETRAVI Expanded Access Program

Plain-language summary

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.

Who can participate

Age range17 Years

SexALL

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Inclusion Criteria: * Patients \<18 years of age. * Patients who have undergone myeloablative or non-myeloablative allogeneic HSCT or CAR T therapy in the Sate of Texas (USA). * Have persistent, increasing, or recurrent infections with EBV, CMV, adenovirus, or BK virus despite standard treatment. * Treating physician must be based in Texas. * Must obtain IRB approval and submit a protocol to FDA with Letter of Authorization from Baylor. Exclusion Criteria: * Patients with active uncontrolled infections unrelated to the viruses mentioned. * Use of certain immunosuppressive agents within 28 days. * Serious uncontrolled medical conditions or relapse of underlying disease.

Trial details

NCT IDNCT07104591

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

Contact for this trial

John Craddock, MD

(832) 824-1583 jacraddo@txch.org

View on ClinicalTrials.gov More Epstein-Barr Virus Infection trials