Adenovirus InfectionPhase 1/2ADV-VSTSNCT04722029
Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
A Phase 1/2 study testing Adenovirus Specific T lymphocytes in people with Adenovirus Infection, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Adenovirus Infection
- What is being tested?
- Adenovirus Specific T lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 0 days to 60 years with one of the following conditions:
- Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are > 28 days post-transplant at the time of screening.
- Patients with underlying malignancy who are receiving or have received chemotherapy within 6 months of screening.
- Patients with known autoimmune or autoinflammatory conditions, not associated with a known underlying primary immunodeficiency
- Patients who are receiving or have received systemic immunosuppressive therapies in the 30 days prior to screening including: biologic agents, calcineurin inhibitors, mTOR inhibitors, or corticosteroid
- Patients without known immunocompromised conditions
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- And must meet at least 1 of the following criteria.
- Documented ADV refractory infection (i.e., DNAemia detected by qualitative or quantitative PCR in the peripheral blood > 14 days or rising viral load in blood despite antiviral therapy >14 days).
- Evidence of refractory ADV end organ disease (proven or probable as previously defined46, including pneumonitis, colitis, hepatitis, hemorrhagic cystitis etc.) despite antiviral therapy >14 days.
- Medical intolerance to anti-viral therapies including renal toxicity (Cr >2) and/or bone marrow suppression (ANC <1500, Hb <10 and/or Plt <50) or gastrointestinal manifestation (grade ≥2 diarrhea), or other related organ injury.
- At high risk for antiviral failure due to history of recurrent ADV reactivations, or recently started on increased immunosuppressants.
- Negative pregnancy test in female patients if applicable (childbearing potential)
- Written informed consent and/or signed assent line from patient, parent or legal guardian prior to any study-related procedures.
Who cannot join
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment
- Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg/kg/day or ≥ 20mg/day at the time of enrollment
- Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)
- Evidence of uncontrolled infection (except ADV) as follows:
- Bacterial infections - patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment
- Fungal infections - patients must be receiving definitive systemic anti-fungal therapy and evidence of response/stabilization on therapy for 1 week prior to enrollment
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- Progressing infection is defined as hemodynamic instability attributable to sepsis, or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection
- Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)
- Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory adenovirus infection(s)
- During the study, treatment with other investigational anti-adenoviral agents is prohibited until Week 12.
- If patient has been treated with CMX001 (brincidofovir, BCV) prior to ADV-VST enrollment, BCV must be discontinued for at least 72 hours prior to ADV-VSTs infusion for washout based on known geometric mean elimination half-life of BCV (8 to 12 hours). Any medical condition which could compromise participation in the study according to the investigator's assessment
- Known HIV infection
- Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
- Known hypersensitivity to iron dextran
- Patients unwilling or unable to comply with the protocol or unable to give informed consent.
- Known human anti-mouse antibodies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Melinda Triplet, RN, 614-722-6039, Melinda.Triplet@nationwidechildrens.org
About this study
Official title: Open-Label Pilot Study of Haploidentical Donor Adenovirus Specific T Lymphocytes (ADV-VSTS) for the Treatment of Refractory Adenovirus Infection and/or Disease in Hospitalized Patients
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
- Conditions
- Adenovirus Infection
- Being tested
- Adenovirus Specific T lymphocytes
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adenovirus Specific T lymphocytesBiological
ADV-VSTs is being proposed for the treatment of refractory ADV infection and/or disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation/IFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs.
| Study group | Role | What they receive |
|---|---|---|
| Donor | No intervention | Donors will be evaluated to determine suitability to undergo apheresis collection and their infectious disease status. Donor evaluation will include history and physical examination, laboratory tests, FDA- approved donor testing of communicable diseases (HIV, HVB, HCV, HTLV-I, II, WNV, T. pallidum, T. cruzi, and Zika virus), ABO and Rh typing, pregnancy tests, and donor serology for ADV. Qualified donors will undergo leukapheresis. Collection will proceed for 2 hours or 2 blood volumes, whichever occurs first. |
| Recipient | Experimental | Recipient will undergo a screening period that will include history and physical examination, laboratory tests, performance status, HLA typing and pregnancy test (if needed).
Qualified patients will receive ADV-VSTS infusion from haploidentical donors up to a maximum of 5.0 x 104 interferon gamma-negative cells/kg. All patients will be followed for laboratory and clinical response, safety, efficacy and tolerance. Receives: Biological: Adenovirus Specific T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety by measuring unacceptable toxicities
Safety will be assess at 28 days post ADV-VSTS infusion. Safety is defined as presentation of unacceptable toxicities, measured by grade III-IV acute GVHD within 28 days, solid organ rejection/ graft failure within 28 days, grade >4 infusional toxicity within 7 days of infusion, and grade 4-5 adverse events within 28 days per CTCAE 5.0.
Measured: 7-28 days
Efficacy by measuring viral load
Percentage of patients with ≥1 log decrease in ADV viral load. ADV viral load will be monitored by quantitative ADV PCR weekly until negative PCR. Response will be assess on day 28 post ADV-VSTS infusion defined as complete response, partial response, stable disease or progressive disease
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenovirus InfectionStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eunkyung Song, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722029
- Sponsor's protocol ID
- STUDY00001291
- Acronym
- ADV-VSTS
- Status last verified
- May 2025
- First submitted
- 20 Jan 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Pilot Study of Haploidentical Donor Adenovirus Specific T Lymphocytes (ADV-VSTS) for the Treatment of Refractory Adenovirus Infection and/or Disease in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT04722029
- Acronym / sponsor ID
- ADV-VSTS / STUDY00001291
- Conditions
- Adenovirus Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 25 Jan 2021 (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 open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donor | No intervention | –Donors will be evaluated to determine suitability to undergo apheresis collection and their infectious disease status. Donor evaluation will include history and physical examination, laboratory tests, FDA- approved donor testing of communicable diseases (HIV, HVB, HCV, HTLV-I, II, WNV, T. pallidum, T. cruzi, and Zika virus), ABO and Rh typing, pregnancy tests, and donor serology for ADV. Qualified donors will undergo leukapheresis. Collection will proceed for 2 hours or 2 blood volumes, whichever occurs first. |
| Recipient | Experimental | Biological: Adenovirus Specific T lymphocytesRecipient will undergo a screening period that will include history and physical examination, laboratory tests, performance status, HLA typing and pregnancy test (if needed). Qualified patients will receive ADV-VSTS infusion from haploidentical donors up to a maximum of 5.0 x 104 interferon gamma-negative cells/kg. All patients will be followed for laboratory and clinical response, safety, efficacy and tolerance. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Age 0 days to 60 years with one of the following conditions:
- And must meet at least 1 of the following criteria.
- Negative pregnancy test in female patients if applicable (childbearing potential)
- Written informed consent and/or signed assent line from patient, parent or legal guardian prior to any study-related procedures.
Key exclusion criteria (16 listed)
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab, cytoxan, or other T-cell depleting drugs or monoclonal antibodies within 28 days from enrollment
- Receiving corticosteroid (prednisone equivalent) ≥ 0.5mg/kg/day or ≥ 20mg/day at the time of enrollment
- Recipients of allogeneic hematopoietic stem cell transplant (bone marrow, peripheral blood or umbilical cord blood)
- Evidence of uncontrolled infection (except ADV) as follows:
- Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30% (Table 5)
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 |
|---|---|---|
| Adenovirus Specific T lymphocytesADV-VSTs is being proposed for the treatment of refractory ADV infection and/or disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation/IFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs. | Biological | Recipient |
Primary outcome
Safety by measuring unacceptable toxicities
Time frame: 7-28 days
Safety will be assess at 28 days post ADV-VSTS infusion. Safety is defined as presentation of unacceptable toxicities, measured by grade III-IV acute GVHD within 28 days, solid organ rejection/ graft failure within 28 days, grade >4 infusional toxicity within 7 days of infusion, and grade 4-5 adverse events within 28 days per CTCAE 5.0.
Efficacy by measuring viral load
Time frame: 28 days
Percentage of patients with ≥1 log decrease in ADV viral load. ADV viral load will be monitored by quantitative ADV PCR weekly until negative PCR. Response will be assess on day 28 post ADV-VSTS infusion defined as complete response, partial response, stable disease or progressive disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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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.
Eunkyung Song, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adenovirus Specific T lymphocytes in people with Adenovirus Infection, run by Nationwide Children's Hospital at 1 site in United States.
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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melinda Triplet (6147226039, Melinda.Triplet@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety by measuring unacceptable toxicities (time frame: 7-28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 13 May 2025.