Solid Organ TransplantPhase 2NCT04331275
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
A Phase 2 study testing Viral Specific T-cells (VSTs) in people with Solid Organ Transplant and Viral Infection, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Solid Organ Transplant, Viral Infection
- What is being tested?
- Viral Specific T-cells (VSTs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2020to Sep 2032
- Phase
- Phase 2
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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Blood adenovirus PCR ≥1,000
- Blood CMV PCR ≥ 500
- Blood EBV PCR ≥ 1,000
- Plasma BKV PCR >1,000
- Plasma JC Virus PCR > 1,000
- Evidence of invasive adenovirus infection. Adenovirus infection will be defined as the presence of adenoviral positivity as detected by PCR or culture from one site such as stool or blood or urine or nasopharynx. Adenovirus disease will be defined as the presence of adenoviral positivity as detected by culture or PCR from more than 2 sites such as stool or blood or urine or nasopharynx.
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- Evidence of invasive CMV infection, e.g. pneumonitis, retinitis, colitis.
- Evidence of 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.
- Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, BK viruria or BK nephropathy
- Evidence of PML or other CNS infection due to JC virus
- Clinical status must allow tapering of steroids to < 0.5mg/kg prednisone or other steroid equivalent, or a clinically acceptable steroid dose at the discretion of the PI
- Age > 1 day
- Must be able to receive VST infusion in Cincinnati
Who cannot join
- Uncontrolled bacterial or fungal infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Solid Organ Transplant
The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to treat viral infections that may happen after solid organ transplant (SOT). VSTs are cells specially designed to fight viral infections that may happen after a solid organ transplant. These cells are created from a blood sample collected from the study participant.
Solid organ transplant and the use of immunosuppressive medications reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Reduction of immunosuppression may put the organ at risk of rejection. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections and minimize complications.
- Conditions
- Solid Organ Transplant, Viral Infection
- Being tested
- Viral Specific T-cells (VSTs)
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viral Specific T-cells (VSTs)Biological
VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.
| Study group | Role | What they receive |
|---|---|---|
| Viral Specific T-cells (VSTs) | Experimental | Not described Receives: Biological: Viral Specific T-cells (VSTs) |
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
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start18 Aug 2020
- Primary completionSep 2030 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Hoxworth Blood Center
- Responsible party
- Sponsor
- Investigators
- Stella Davies, MBBS, PhD, MRCP, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331275
- Sponsor's protocol ID
- 2020-0042
- Status last verified
- Oct 2026
- First submitted
- 31 Mar 2020
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No