CytomegalovirusPhase 2NCT05664126
Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation
A Phase 2 study testing VST infusion and CliniMACS in people with Cytomegalovirus and Adenovirus, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cytomegalovirus, Adenovirus
- What is being tested?
- VST infusion and CliniMACS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 Dec 2029
- Phase
- Phase 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.
- Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.
- Patients have no suspected or confirmed GVHD.
- Availability of haploidentical donor for isolation of virus-specific T-cells.
- Have not received a Donor Lymphocyte Infusion in the past 4 weeks.
- Female patients of childbearing age must have a negative pregnancy test.
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- Subject, parent, or guardian are capable of giving signed informed consent.
- Patients must have a shortening fraction >26% or left ventricular ejection fraction >40%.
- Patients must have a bilirubin less than or equal to 2.5mg/dL and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal.
- Patients must have an estimated glomerular filtration rate (GFR) greater than 60mL/min/1.73m2 (may use estimated GFR that is auto calculated in the EHR).
- Patients must be free of severe infection which upon determination of the principal investigator precludes therapy with VST.
- Patients must have FVC >50% predicted or able to maintain pulse oximetry saturation > 92% on room air.
- Gut diarrhea <1 liter/day (adults) or <20mL/kg/day (children) or if unable to quantify, then occurrence of 4 stools per day above baseline.
- Patients must have engrafted with an ANC >500 cells/mm3 for 3 consecutive days.
- Age ≥18 years.
- At least single haplotype matched (≥3/6) family member.
- Donor will be identical to the stem cell donor (Cohort A) or different from the stem cell donor (Cohort B).
- HIV negative.
- For females of childbearing age: Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment AND not lactating with intent to breastfeed.
- Regarding donation eligibility, is identified as either having completed the process of donor eligibility determination as outlined in 21CFR 1271 and agency guidance or does not meet 21CFR 1271 eligibility requirements but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21CFR.
- Identified recipient with CMV and/or ADV reactivation post-HCT.
Who cannot join
- Active GVHD.
- Pregnancy.
- Inability to provide consent.
- Need for vasopressor or ventilatory support Patients receiving steroids >0.5 mg/kg prednisone equivalent at the time of VST infusion
- Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.
- Receipt of Thymoglobulin or Alemtuzumab within 30 days of VST infusion.
- Other severe uncontrolled concurrent infections (i.e. bacterial or fungal) that are not yet controlled on antimicrobial therapies.
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
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
Naik Swati, MD, 866-278-5833, referralinfo@stjude.org
Naik Swati, MD
About this study
The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection.
Primary objective
Read more
To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion.
When the initial viral load is <1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection.
Secondary objectives
- Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT.
- Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion.
- Assess the persistence of response for 6 months post-infusion.
Read the detailed description
The study will have 2 cohorts. Cohort A will include haploidentical donor who is identical to the stem cell donor. Cohort B will include haploidentical donor who is different from the stem cell donor. Seropositive donors will be screened for the presence of CMV- and ADV-specific T-cells using a functional flow cytometry assay. The donor will be considered suitable if the percentage of CD3+/IFN-γ+ cells is greater than 0.01% of CD3+ T-cells. Donor leukocytes will be collected using the Spectra Optia system. CMV- and ADV-specific T-cells will be isolated from donor leukocytes by 'IFN-γ-capture' technology using the Prodigy device over a 24-36 hour period and infused.
- Conditions
- Cytomegalovirus, Adenovirus
- Being tested
- VST infusion, CliniMACS
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VST infusionDrug
Also called The product is a suspension of allogenic peripheral blood VSTs enriched based on their secretion of IFN-γ after stimulation with the appropriate antigen
single intravenous (IV) infusion.
CliniMACSDevice
Also called ClinMACS Prodigy
Cells infusions are prepared using the ClinMACS
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Cohort A will include haploidentical donor who is identical to the stem cell donor.
The first 5 patients will be enrolled in Cohort A. If safety criteria are met, cohort B will be open for enrollment. Receives: Drug: VST infusion; Device: CliniMACS |
| Cohort B | Experimental | Cohort B will include haploidentical donor who is different from the stem cell donor Receives: Drug: VST infusion; Device: CliniMACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of reduction of CMV and/or ADV viral load
The primary objective of this clinical study is to evaluate the efficacy of adoptively transferred CMV- and ADV-specific haploidentical T-cells in patients who have undergone allogeneic HCT. This primary endpoint is defined as ≥1 log10 reduction in CMV and/or ADV viral load 4 weeks after VST infusion. When the initial viral load is <1 log10 above the threshold of detection the endpoint will be a reduction to below the threshold of detection. The success rate will be evaluated using descriptive statistics (sample proportion and standard error). Patients with both CMV and ADC detected will count as success if reduction occurs in one or both of CMV and ADV.
Measured: 4 weeks after VST infusion
Secondary outcomes (8)
Incidence of infusion-related grade 3-5 adverse events 24 hours after infusion
The incidence of infusion-related grade 3-5 adverse events will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Measured: 24 hours after infusion
Incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy
The incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Measured: 4 weeks after VST infusion
Incidence of Grade 3-4 Neurotoxicity of any duration
The incidence of Grade 3-4 Neurotoxicity of any duration will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Measured: 4 weeks after VST infusion
Incidence of Grade 3-4 GVHD
The incidence of Grade 3-4 GVHD will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Measured: 4 weeks after VST infusion
Incidence of grade 3-5 non hematologic toxicities attributable to VST
The incidence of grade 3-5 non hematologic toxicities attributable to VST will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Measured: 4 weeks after VST infusion
Incidence of secondary graft failure attributable to VST
The incidence of secondary graft failure attributable to VST will be estimated using descriptive statistics (sample proportions and cumulative incidence curves with standard errors)
Measured: 4 weeks after VST infusion
Proportion of patients who achieve a negative viral load result at 3 months
The proportion of patients who achieve a negative viral load result at 3 months will be assessed using descriptive statistics (sample proportions with standard errors)
Measured: 3 months after VST infusion
Persistence of response at 6 months post-infusion
The persistence of response at 6 months post-infusion will be assessed using descriptive statistics (sample proportions with standard errors)
Measured: 6 months after VST infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Aug 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CytomegalovirusStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naik Swati, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664126
- Sponsor's protocol ID
- VSTHCT
- Other IDs
- NCI-2023-03240
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2022
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05664126
- Acronym / sponsor ID
- VSTHCT
- Conditions
- Cytomegalovirus, Adenovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Dec 2022 (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.
The investigators want to learn if CMV- and ADV-specific T-cells (cells that fight infections) isolated (selected) from a donor using an automated medical device can be a safe treatment for treating patients with CMV, and ADV after transplant.This study will test the effects and safety of giving VSTs produced here at St. Jude in treating the participant's infection.
Primary objective
To determine the efficacy of VSTs to achieve a ≥1 log10 reduction in CMV and/or ADV viral load in the peripheral blood 4 weeks after VST infusion.
When the initial viral load is <1 log10 above the threshold of detection, the objective is to achieve a reduction to below the threshold of detection.
Secondary objectives
- Determine the safety of VSTs when used to treat CMV and/or ADV viremia post-HCT.
- Determine the proportion of patients who achieve a negative viral load at 3 months post-infusion.
- Assess the persistence of response for 6 months post-infusion.
Detailed description
The study will have 2 cohorts. Cohort A will include haploidentical donor who is identical to the stem cell donor. Cohort B will include haploidentical donor who is different from the stem cell donor. Seropositive donors will be screened for the presence of CMV- and ADV-specific T-cells using a functional flow cytometry assay. The donor will be considered suitable if the percentage of CD3+/IFN-γ+ cells is greater than 0.01% of CD3+ T-cells. Donor leukocytes will be collected using the Spectra Optia system. CMV- and ADV-specific T-cells will be isolated from donor leukocytes by 'IFN-γ-capture' technology using the Prodigy device over a 24-36 hour period and infused.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: VST infusion, Device: CliniMACSCohort A will include haploidentical donor who is identical to the stem cell donor. The first 5 patients will be enrolled in Cohort A. If safety criteria are met, cohort B will be open for enrollment. |
| Cohort B | Experimental | Drug: VST infusion, Device: CliniMACSCohort B will include haploidentical donor who is different from the stem cell donor |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- Patients who have undergone haploidentical HCT or a matched-sibling/matched-unrelated donor HCT, and have CMV and/or ADV detected by PCR in the peripheral blood refractory to antiviral therapy per institutional BMTCT SOP 20.05.
- Definition of "refractory" viremia is persistent positive CMV or ADV viremia after 14 days of treatment per institutional SOP, or an increasing copy number (≥1 log) after 7 days of treatment.
- Patients have no suspected or confirmed GVHD.
- Availability of haploidentical donor for isolation of virus-specific T-cells.
- Have not received a Donor Lymphocyte Infusion in the past 4 weeks.
Key exclusion criteria (7 listed)
- Active GVHD.
- Pregnancy.
- Inability to provide consent.
- Need for vasopressor or ventilatory support Patients receiving steroids >0.5 mg/kg prednisone equivalent at the time of VST infusion
- Donor Lymphocyte Infusion within 4 weeks prior to VST infusion.
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 |
|---|---|---|
| VST infusionAlso: The product is a suspension of allogenic peripheral blood VSTs enriched based on their secretion of IFN-γ after stimulation with the appropriate antigensingle intravenous (IV) infusion. | Drug | Cohort A, Cohort B |
| CliniMACSAlso: ClinMACS ProdigyCells infusions are prepared using the ClinMACS | Device | Cohort A, Cohort B |
Primary outcome
Degree of reduction of CMV and/or ADV viral load
Time frame: 4 weeks after VST infusion
The primary objective of this clinical study is to evaluate the efficacy of adoptively transferred CMV- and ADV-specific haploidentical T-cells in patients who have undergone allogeneic HCT. This primary endpoint is defined as ≥1 log10 reduction in CMV and/or ADV viral load 4 weeks after VST infusion. When the initial viral load is <1 log10 above the threshold of detection the endpoint will be a reduction to below the threshold of detection. The success rate will be evaluated using descriptive statistics (sample proportion and standard error). Patients with both CMV and ADC detected will count as success if reduction occurs in one or both of CMV and ADV.
8 secondary outcomes
Incidence of infusion-related grade 3-5 adverse events 24 hours after infusion
Time frame: 24 hours after infusion
Incidence of AEs related to grade 3-4 cytokine release syndrome (CRS), or grade 1-2 CRS persist beyond 72 hours despite therapy
Time frame: 4 weeks after VST infusion
Incidence of Grade 3-4 Neurotoxicity of any duration
Time frame: 4 weeks after VST infusion
Incidence of Grade 3-4 GVHD
Time frame: 4 weeks after VST infusion
Incidence of grade 3-5 non hematologic toxicities attributable to VST
Time frame: 4 weeks after VST infusion
Incidence of secondary graft failure attributable to VST
Time frame: 4 weeks after VST infusion
Proportion of patients who achieve a negative viral load result at 3 months
Time frame: 3 months after VST infusion
Persistence of response at 6 months post-infusion
Time frame: 6 months after VST infusion
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 23 Feb 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St.JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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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.
Naik Swati, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VST infusion and CliniMACS in people with Cytomegalovirus and Adenovirus, run by St. Jude Children's Research 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 21 inclusion and 7 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 23 Feb 2026. 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 phase mean?
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 Naik Swati, MD (866-278-5833, referralino@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of reduction of CMV and/or ADV viral load (time frame: 4 weeks after VST infusion). 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 23 Feb 2026.