Epstein-Barr Virus InfectionNCT07104591
TETRAVI Expanded Access Program
A study testing HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes) in people with Epstein-Barr Virus Infection and Cytomegalovirus Infections, run by Baylor College of Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Epstein-Barr Virus Infection, Cytomegalovirus Infections, Adenovirus Infection
- What is being tested?
- HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access Use of Multivirus-Specific Cytotoxic T-Lymphocytes for Pediatric Patients With EBV, CMV, Adenovirus, or BK Virus Infections Post Allogeneic Stem Cell Transplant
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.
Read the detailed description
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.
- Conditions
- Epstein-Barr Virus Infection, Cytomegalovirus Infections, Adenovirus Infection, BK Virus Infection, JC Virus Infection, Viral Infections Post-Transplant
- Being tested
- HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes)
- Medical subject headings
- Epstein-Barr Virus Infections, Cytomegalovirus Infections, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus InfectionStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Craddock, MD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104591
- Sponsor's protocol ID
- H-44843 TETRAVI EAP
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of Multivirus-Specific Cytotoxic T-Lymphocytes for Pediatric Patients With EBV, CMV, Adenovirus, or BK Virus Infections Post Allogeneic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT07104591
- Acronym / sponsor ID
- H-44843 TETRAVI EAP
- Conditions
- Epstein-Barr Virus Infection, Cytomegalovirus Infections, Adenovirus Infection, BK Virus Infection, JC Virus Infection, Viral Infections Post-Transplant
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes)Banked, partially HLA-matched virus-specific T cells (VSTs) directed against EBV, CMV, adenovirus, and BK virus. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Craddock, MD study chair
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing HLA-matched VSTs (Multivirus-specific Cytotoxic T Lymphocytes) in people with Epstein-Barr Virus Infection and Cytomegalovirus Infections, run by Baylor College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Craddock, MD ((832) 824-1583, jacraddo@txch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.