A Phase 1/2 interventional study of Virus Specific T-cell (VST) infusion in Cytomegalovirus Infections, Adenovirus Infection and EBV Infection, sponsored by Pediatric Transplantation & Cellular Therapy Consortium. Active, not recruiting at 30 sites in United States. Per ClinicalTrials.gov, last updated 2025-05-11.
Sponsored by Pediatric Transplantation & Cellular Therapy Consortium · Phase 1/2, Interventional, and Treatment
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Among 178 studies in Cytomegalovirus Infections with a site in United States — 15 open to participants now, 21 under way, 2 of them phase 3. Cytomegalovirus Infections · United States.
Among the 178 studies in Cytomegalovirus Infections with a site in United States, this one is the 79th largest by enrollment of the 139 interventional ones that give a count, is one of 5 that started in 2018, is one of 7 in phase 1/2, reaches primary completion later than 2 of the 20 other live ones, and was the 134th registered.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
Browse Cytomegalovirus Infections studies →15 of the 178 studies in Cytomegalovirus Infections with a site in United States are open now. Recruiting first, the newest first:
New York Medical College · Sites in United States
Ages 1 days–30 yrs
Amivas Inc. · Sites in United States, Australia
Ages 18+
Jessie L. Alexander · Sites in United States
Ages 1 mo–65 yrs
Monica Bhatia · Sites in United States
Ages 3 mo–26 yrs
University of Wisconsin, Madison · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
178 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 48 · Phase 2 47 · Phase 3 25 · Phase 4 13
First in 1996; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 52 is below the median of 64 across 240 interventional studies indexed under Cytomegalovirus Infections.
Median enrollment 61 across the 139 interventional studies, 153 across the 25 observational. Of the 151 that completed or were terminated, 44 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
60 of 178 have an industry lead sponsor. The 10 most frequent:
Pediatric Transplantation & Cellular Therapy Consortium is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Pediatric Transplantation & Cellular Therapy Consortium has 1 study filed under Cytomegalovirus Infections — fewer than ten, so there is no comparison to draw.
8 of the studies in Cytomegalovirus Infections with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06407232Phase 3University of Wisconsin, MadisonLetermovir (Prevymis) for CMV in Kidney and Pancreas Transplant Recipients | 2027-08 |
| NCT03354728City of Hope Medical CenterMulti-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant | 2026-12-11 |
| NCT06066957University of PennsylvaniaOpen Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients | 2026-12-15 |
| NCT03266640New York Medical CollegeVirus Specific Cytotoxic T-Lymphocytes (CTLs) for Refractory Cytomegalovirus (CMV) | 2026-12-31 |
| NCT05234723IRCCS Azienda Ospedaliero-Universitaria di BolognaGanciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients | 2027-02-28 |
Add all 8 to your calendar (.ics) → With an account.
Among the 178 studies in Cytomegalovirus Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.
The primary purpose of the study is to evaluate whether most closely HLA-matched multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus.
Reconstitution of anti-viral immunity by donor-derived VSTs has shown promise in preventing and treating infections associated with CMV, EBV and adenovirus post-transplant. However, the time required to prepare patient-specific products and lack of virus-specific memory T cells in cord blood and seronegative donors, limits their value. An alternative is to use banked partially HLA-matched allogeneic VSTs. A prior phase II study at Baylor College of Medicine using trivirus-specific VSTs generated using monocytes and EBV-transformed B cells gene-modified with a clinical grade adenoviral vector expressing CMV-pp65 to activate and expand specific T cells showed the feasibility, safety and activity of this approach for the treatment of refractory CMV, EBV and Adenovirus infections. More recent protocols utilizing synthetic viral peptide pools allow ex vivo expansion of T-cells targeting multiple viral antigens in 10-12 days without use of viral transduction.
The study will evaluate whether partially-HLA matched allogeneic multivirus-specific VSTs, activated using overlapping peptide libraries spanning immunogenic antigens from CMV, adenovirus and EBV, will be safe and produce anti-viral effects in immunodeficient recipients infected with one of more of the targeted viruses that are persistent despite conventional anti-viral therapy.
This study will evaluate safety and efficacy of partially-matched VST therapy in A) patients who have persistent viral infections in the post-HSCT period, and B) patients with primary immunodeficiency conditions who have persistent viral infections and have not undergone HSCT.
The study agent will be assessed for safety and antiviral activity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who have received any type of transplant or who have a primary immunodeficiency disorder will be eligible if they have CMV, adenovirus, and/or EBV infection/disease with failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy.
Patients must meet one of the following criteria:
Treatment of the following persistent or infections despite standard therapy:
For EBV infection, standard therapy is defined as rituximab given at 375 mg/m2 in patients for 1-4 doses with a CD20+ tumor.
Additional Inclusion Criteria:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study will evaluate whether partially-HLA matched allogeneic multivirus-specific VSTs, activated using overlapping peptide libraries spanning immunogenic antigens from CMV, adenovirus and EBV, will be safe and produce anti-viral effects in immunodeficient recipients infected with one of more of the targeted viruses that are persistent despite conventional anti-viral therapy.
Biological: Virus Specific T-cell (VST) infusion
Patients will receive partially HLA-matched VSTs as a single infusion. Patients who have a partial response (\>1 log decrease in viral load without clearance) or no response and do not have treatment-related dose-limiting toxicities are eligible to receive up to 3 additional doses from day 30 after the initial infusion and at 2 weekly intervals thereafter. The viral load of the virus (or viruses) that patients are initially treated for are monitored by viral PCR.
Feasibility to identify suitable HLA matched VST products
Feasibility will be defined as the ability of the investigators to identify suitable partially HLA- matched VST products from the VST bank at Children's National Medical Center for referred study subjects. The percentage of referred patients with potential partially-matched VST products identified will be recorded, as will timing between patient referral and treatment.
Time frame: 30 days
Incidence of Treatment-Emergent Adverse Events
The safety endpoint, dose-limiting toxicity (DLT), will be defined as acute GvHD grades III-IV or grades 3-5 infusion-related adverse events or grades 4-5 non-hematological adverse events related to the T cell product within 30 days of each VST dose and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities as defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03.
Time frame: 30 days
Efficacy of VST at 30 days as measured by viral load
Peripheral blood and, where relevant, stool and urine will be monitored for CMV, EBV, and/or adenovirus viral load. For patients with multiple viral infections, the response against the primary viral target will determine the classification. For the infection under treatment response in viral load will be assessed at 30 days after the first VST infusion
Time frame: 30 days
Reconstitution of Antiviral Immunity following VST infusions
Patient serum and peripheral blood mononuclear cells will be monitored for virus-specific activity during the 3 months following VST infusion by the following measures: 1. T cell phenotyping by flow cytometry (including % CD3, CD4, CD8, TCRalpha/beta and CD45RA-/CCR7+, among other markers) 2. Antiviral T cell responses to CMV, EBV, and/or Adenovirus antigens by IGN-g ELIspot (spot forming units) and Intracellular cytokine staining ( %IFN-gamma and TFNa+ of CD4 and CD8 cells) 3. T cell repertoire and antiviral specificity by TCR sequencing (%clonotype frequencies)
Time frame: 3 months
Persistence of infused VSTs
Persistence of infused T cells will be monitored at 1 month and 3 months following VST infusion using deep sequencing and additional tests as indicated to track the TCR v-beta repertoire in the patient peripheral blood prior to and post-infusion.
Time frame: 1 month and 3 months
Effects on Clinical Signs of Viral Infection
If a patient has organ involvement, clinical response will be monitored. For patients with EBV lymphoma and measurable disease, response will be assessed by RECIST criteria.
Time frame: 3 months
Survival
Overall survival at 6 and 12 months post VST infusion will be computed.
Time frame: 6 months and 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2018 (actual). Primary completion is estimated for Jun 2025, 84 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Pediatric Transplantation & Cellular Therapy Consortium