Viral InfectionPhase 2NCT02532452
Third Party Viral Specific T-cells (VSTs)
A Phase 2 study testing Viral Specific VST Infusion in people with Viral Infection and Viral Reactivation, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial summary
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections. Read more about this study
- Who is it for?
- Ages 2 days and older
- Conditions the study is for
- Viral Infection, Viral Reactivation, Infection in an Immunocompromised Host
- What is being tested?
- Viral Specific VST Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Sep 2015to 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 2 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Immunocompromised patient with evidence of viral infection or reactivation
- Age >1 day
- Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
- Must be able to receive CTL infusion in Cincinnati
- Informed consent obtained by PI or sub-investigator either in person or by phone
Who cannot join
- Active acute GVHD grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy requiring treatment with chemotherapy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
- Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Grimley, MD contact
United States4 sites, 3 recruiting
- Recruiting
Akron Children's Hospital
Akron, Ohio, 44308
Courtney Culbertson, CNP, 330-543-3338, cculbertson@akronchildrens.org
Megan Sampson, MD
- Completed
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jamie Wilhelm, 513-803-1102, Jamie.Wilhelm@cchmc.org
Michael Grimley, MD
- Recruiting
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
Nicole Szuminski, MS, RN, CCRC, nicole.szuminski@osumc.edu
Polina Shindiapina, MD, PhD
About this study
Official title: Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Read the detailed description
Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.
- Being tested
- Viral Specific VST Infusion
- Keywords
- Epstein-Barr Virus (EBV), Adenovirus (ADV), Cytomegalovirus (CMV), T-Cells, Donor, BK virus (BKV)
- Medical subject headings
- Virus Diseases, Epstein-Barr Virus Infections, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral Specific VST InfusionBiological
VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following:
- Blood adenovirus PCR ≥ 1,000
- Blood CMV PCR ≥ 500
- Blood EBV PCR ≥ 9,000
- Plasma BKV PCR >1,000
- Plasma JC Virus PCR > 1,000
- Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites
- Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis
- Evidence of invasive EBV disease/infection, EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies
- Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy
- Evidence of PML or other CNS infection due to JC virus
| Study group | Role | What they receive |
|---|---|---|
| Viral Specific VST Infusion | Experimental | 3rd party VST infusion Receives: Biological: Viral Specific VST Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful production of viral specific T-cells
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Measured: Within 30 days post culture initiation
Percentage of patients who do not have infusional toxicity
Patients will be monitored for infusional toxicity
Measured: Through 30 minutes post infusion
Incidence of GVHD associated with VST infusion
Patients will be monitored for the development of VST associated GVHD
Measured: Through 30 days after infusion
Secondary outcomes (2)
Presence of viral-specific T-cells
Presence of viral-specific T-cells in the participant's blood will be assessed by Elispot assay
Measured: At 30 days after infusion
Viral burden
The viral burden will be assessed using the protocol-defined efficacy assessment.
Measured: At 30 days after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study start2 Sep 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Grimley, MD, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532452
- Sponsor's protocol ID
- 2015-4184
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2015
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rubinstein JD, Pham G, Sridharan A, Khoury R, Wang YM, Hudda Z, Wilhelm J, Lichtenstein DA, Heyenbruch D, Cancelas JA, Davies SM, Lutzko C, Grimley MS. Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction. Blood Adv. 2025 Dec 23;9(24):6305-6313. doi: 10.1182/bloodadvances.2025017097.
PubMed 40991376Galletta TJ, Lane A, Lutzko C, Leemhuis T, Cancelas JA, Khoury R, Wang YM, Hanley PJ, Keller MD, Bollard CM, Davies SM, Grimley MS, Rubinstein JD. Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. Transplant Cell Ther. 2023 May;29(5):305-310. doi: 10.1016/j.jtct.2023.01.027. Epub 2023 Feb 3.
PubMed 36736781Rubinstein JD, Zhu X, Leemhuis T, Pham G, Ray L, Emberesh S, Jodele S, Thomas S, Cancelas JA, Bollard CM, Hanley PJ, Keller MD, Grimley O, Clark D, Clark T, Lindestam Arlehamn CS, Sette A, Davies SM, Nelson AS, Grimley MS, Lutzko C. Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. Blood Adv. 2021 Sep 14;5(17):3309-3321. doi: 10.1182/bloodadvances.2021004456.
PubMed 34473237Nelson AS, Heyenbruch D, Rubinstein JD, Sabulski A, Jodele S, Thomas S, Lutzko C, Zhu X, Leemhuis T, Cancelas JA, Keller M, Bollard CM, Hanley PJ, Davies SM, Grimley MS. Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients. Blood Adv. 2020 Nov 24;4(22):5745-5754. doi: 10.1182/bloodadvances.2020003073.
PubMed 33216887
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT02532452
- Acronym / sponsor ID
- 2015-4184
- Keywords
- Epstein-Barr Virus (EBV), Adenovirus (ADV), Cytomegalovirus (CMV), T-Cells, Donor, BK virus (BKV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 2 Sep 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 25 Aug 2015 (estimated)
- 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 purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.
Detailed description
Viral reactivation and infection is a major cause of morbidity in immunocompromised patients (including HSCT recipients). In this study we will draw blood from unrelated (third party) donors and use the blood to generate viral specific T-cells (VSTs) with specificity for Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (ADV), BK virus (BKV), and JC Virus. The VSTs will be infused into immunocompromised children with specific viral infections (EBV, CMV, ADV, BKV , or JC virus). Cells will be selected for infusion based on the recipient's HLA type and the viral specificity of the cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viral Specific VST Infusion | Experimental | Biological: Viral Specific VST Infusion3rd party VST infusion |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Immunocompromised patient with evidence of viral infection or reactivation
- Age >1 day
- Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent
- Must be able to receive CTL infusion in Cincinnati
Key exclusion criteria (5 listed)
- Active acute GVHD grades II-IV
- Uncontrolled bacterial or fungal infection
- Uncontrolled relapse of malignancy requiring treatment with chemotherapy
- Infusion of ATG or alemtuzumab within 2 weeks of VST infusion
- Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days
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 |
|---|---|---|
| Viral Specific VST InfusionVSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following: * Blood adenovirus PCR ≥ 1,000 * Blood CMV PCR ≥ 500 * Blood EBV PCR ≥ 9,000 * Plasma BKV PCR >1,000 * Plasma JC Virus PCR > 1,000 * Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites * Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis * Evidence of invasive EBV disease/infection, EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies * Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy * Evidence of PML or other CNS infection due to JC virus | Biological | Viral Specific VST Infusion |
Primary outcome
Successful production of viral specific T-cells
Time frame: Within 30 days post culture initiation
Of the patients who had a VST culture initiated, successful production of VST cells is defined as meeting the protocol-defined release criteria.
Percentage of patients who do not have infusional toxicity
Time frame: Through 30 minutes post infusion
Patients will be monitored for infusional toxicity
Incidence of GVHD associated with VST infusion
Time frame: Through 30 days after infusion
Patients will be monitored for the development of VST associated GVHD
2 secondary outcomes
Presence of viral-specific T-cells
Time frame: At 30 days after infusion
Viral burden
Time frame: At 30 days after 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 4 Sep 2026.
- Derived from this study: PubMed 40991376Rubinstein JD, Pham G, Sridharan A, Khoury R, Wang YM, Hudda Z, Wilhelm J, Lichtenstein DA, Heyenbruch D, Cancelas JA, Davies SM, Lutzko C, Grimley MS. Outcomes with third-party virus-specific T cells after the use of single-antigen cell lines to predict HLA restriction. Blood Adv. 2025 Dec 23;9(24):6305-6313. doi: 10.1182/bloodadvances.2025017097.
- Derived from this study: PubMed 36736781Galletta TJ, Lane A, Lutzko C, Leemhuis T, Cancelas JA, Khoury R, Wang YM, Hanley PJ, Keller MD, Bollard CM, Davies SM, Grimley MS, Rubinstein JD. Third-Party and Patient-Specific Donor-Derived Virus-Specific T Cells Demonstrate Similar Efficacy and Safety for Management of Viral Infections after Hematopoietic Stem Cell Transplantation in Children and Young Adults. Transplant Cell Ther. 2023 May;29(5):305-310. doi: 10.1016/j.jtct.2023.01.027. Epub 2023 Feb 3.
- Derived from this study: PubMed 34473237Rubinstein JD, Zhu X, Leemhuis T, Pham G, Ray L, Emberesh S, Jodele S, Thomas S, Cancelas JA, Bollard CM, Hanley PJ, Keller MD, Grimley O, Clark D, Clark T, Lindestam Arlehamn CS, Sette A, Davies SM, Nelson AS, Grimley MS, Lutzko C. Virus-specific T cells for adenovirus infection after stem cell transplantation are highly effective and class II HLA restricted. Blood Adv. 2021 Sep 14;5(17):3309-3321. doi: 10.1182/bloodadvances.2021004456.
- Derived from this study: PubMed 33216887Nelson AS, Heyenbruch D, Rubinstein JD, Sabulski A, Jodele S, Thomas S, Lutzko C, Zhu X, Leemhuis T, Cancelas JA, Keller M, Bollard CM, Hanley PJ, Davies SM, Grimley MS. Virus-specific T-cell therapy to treat BK polyomavirus infection in bone marrow and solid organ transplant recipients. Blood Adv. 2020 Nov 24;4(22):5745-5754. doi: 10.1182/bloodadvances.2020003073.
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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.
Michael Grimley, MD contact
Michael Grimley, MD, MD principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Viral Specific VST Infusion in people with Viral Infection and Viral Reactivation, run by Children's Hospital Medical Center, Cincinnati at 4 sites 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 6 inclusion and 5 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Jamie Wilhelm ((513) 803-1102, Jamie.Wilhelm@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful production of viral specific T-cells (time frame: Within 30 days post culture initiation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532452, which also lists 4 linked publications.
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 4 Sep 2026.