TETRAVI Multivirus CTL for Viral Infections After Transplant
This study is testing a treatment called HLA-matched VSTs (virus-specific T cells) for people who have viral infections (EBV, CMV, Adenovirus, and BK) after an allogeneic hematopoietic stem cell transplant (HSCT). These VSTs are immune cells from a donor that are a partial match to you. The goal is to see if these cells can help your body fight off these infections. You may be able to join if you've had an allogeneic HSCT or certain CAR-T cell therapy. The main goal is to track any side effects from the treatment for 28 days after your last dose. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 47 participants. The phase of the study is not specified.
- What's involved
- You will receive HLA-matched VSTs through an intravenous line. You will stay in the clinic for at least one hour after each infusion, and may receive additional infusions if needed, at least 14 days apart.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your transplant doctor will monitor your virus levels after the cells are given. You will continue to be followed by your doctors after the injection, and treatment-related adverse events will be measured at 28 days after the last dose.
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NCT04013802
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Recruiting
PHASE1All AgesInterventionalTreatmentBaylor College of MedicineInvestigator-initiated
~47 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:HLA-matched VSTs
At a glance
Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment related adverse events.
Measured over 28 days after the last dose of MVST
Conditions
Where it's being run
2 sites across 1 statesTexas2
Study leadership
- John Craddock, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Option 1: Persistent, increasing or recurrent infections despite 7 days of standard therapy;
a. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet, letermovir or cidofovir. 56, 57
i. CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination.
ii. CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx or bronchoalveolar lavage.
b. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir.
i. Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or lung or nasopharynx.
ii. Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or lung or nasopharynx.
c. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor.58
i. EBV infection: defined as: (1) Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR;
ii. (2) Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood.
d. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined (section 1.1.5). Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy.
i. BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine or lung.
ii. BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids or lungs and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site.
e. JC virus: Treatment of JC virus infection or disease without suitable alternative treatment option. Given the high homology (\>90%) between JC and BK and the fact that BKVSTs targeting VP1 and Large T (as targeted in our multivirus MVSTs) have been administered to treat JCV-PML, and produced viral clearance from the cerebrospinal fluid, it is likely that our MVSTs will have efficacy against JC virus. Given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to JML, which is almost uniformly fatal, and the apparent activity of BK virus- directed T cells against JC virus infected cells, we propose including patients with JC virus on this study, unless a suitable alternative therapy is available.
i. JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood.
ii. JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site.
Option 2: Early treatment for single or multiple infections with EBV, CMV, adenovirus, and/or BK virus will be allowed for patients deemed to be unable to tolerate standard therapy. Patients with multiple CMV, EBV, Adenovirus, and BK virus infections are eligible given that at least one infection is persistent despite standard therapy as defined above. Patients with multiple infections or reactivations are eligible to enroll.
Option 3: For patients having adenovirus and BK virus, the requirement to fail one week of standard therapy would be waived if they meet one of the criteria below:
What this trial measures
- Treatment related adverse events.28 days after the last dose of MVST
The primary objective is to measure the safety of MVSTs based on patients with grades 3-5 non-hematologic adverse events that are at least possibly related to the T cell product.