Recruiting
Phase 1
Phase 2

Viral Specific T-cells

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT02048332

Conditions

Allogeneic Stem Cell Transplant

Viral Infection

Viral Reactivation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Viral specific VST Infusion

Study Details

Brief summary:

In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant.

The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death.

Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. 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 an easier way to treat these infections.

Conditions

Allogeneic Stem Cell Transplant

Viral Infection

Viral Reactivation

Study ID

NCT02048332

Start date

Feb 5, 2014

Status verified date

Sep, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recipient 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
  • Recipient must have achieved engraftment with ANC ≥ 500

Exclusion Criteria:

  • 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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Viral Specific VST Infusion

Viral reactivation or infection. VST Reinfusion required.

Interventions

Viral specific VST Infusion

VSTs will be infused into stem cell transplant recipients who have evidence of viral infection or reactivation defined as any of the below:

  • 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 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.

Primary outcome measure

  • Successful production of viral specific T-cells [ Time Frame: Within 30 days post culture initiation ]
  • Percentage of patients who do not have infusional toxicity [ Time Frame: Through 30 minutes post infusion ]
  • Incidence of GVHD associated with VST infusion [ Time Frame: Through 30 days after infusion ]

Central Contacts and Locations

Central contacts

Jamie Wilhelm, BS

(513) 803-1102Jamie.Wilhelm@cchmc.org

Locations

Akron Children's Hospital

Recruiting

Akron, Ohio, United States, 44308

Contacts

Courtney Culbertson, CNP

330-543-3338cculbertson@akronchildrens.org

Principal Investigator:

Megan Sampson, MD

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jamie Wilhelm

513-803-1102Jamie.Wilhelm@cchmc.org

Principal Investigator:

Michael Grimley, MD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • Epstein-Barr Virus (EBV)
  • Adenovirus (ADV)
  • t-cells
  • donor
  • transplant
  • children
  • cytomegalovirus (CMV)
  • BK virus (BKV)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-09-04.