Recruiting
Phase 2

Viral Specific T-Cells

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT02532452

Conditions

Viral Infection

Viral Reactivation

Infection in an Immunocompromised Host

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Viral Specific VST Infusion

Study Details

Brief 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.

Conditions

Viral Infection

Viral Reactivation

Infection in an Immunocompromised Host

Study ID

NCT02532452

Start date

Sep 2, 2015

Status verified date

Sep, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

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
  • 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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Viral Specific VST Infusion

3rd party VST infusion

Interventions

Viral Specific VST Infusion

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

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

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

Michael Grimley, MD

Michael.Grimley@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

The Ohio State University Wexner Medical Center - James Cancer Hospital

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Nicole Szuminski, MS, RN, CCRC

nicole.szuminski@osumc.edu

Principal Investigator:

Polina Shindiapina, MD, PhD

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)
  • Cytomegalovirus (CMV)
  • T-Cells
  • Donor
  • 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.