TETRAVI Expanded Access Program

NCT07104591 | Unknown

• 1 other identifier: H-44843 TETRAVI EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Epstein-Barr Virus Infection; Cytomegalovirus Infections; Adenovirus Infection; BK Virus Infection; JC Virus Infection; Viral Infections Post-Transplant; Post-Allogeneic Stem Cell Transplant Complications

Interventions

HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes) BIOLOGICAL

Banked, partially HLA-matched virus-specific T cells (VSTs) directed against EBV, CMV, adenovirus, and BK virus.

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

MeSH Terms

Conditions

Epstein-Barr Virus Infections; Cytomegalovirus Infections; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections

Study Officials

• John Craddock, MD

  Baylor College of Medicine

  STUDY CHAIR

Central Study Contacts

John Craddock, MD

CONTACT

(832) 824-1583; jacraddo@txch.org

Emily Jobe

CONTACT

(832) 824-4103; edjobe@texaschildrens.org

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07