Recruiting
Phase 2

VSTs

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT04230356

Conditions

Allogeneic Stell Cell Transplant

Viral Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Viral Specific T-cells (VSTs) Scheduled

Viral Specific T-cells (VSTs) Treatment

Study Details

Brief summary:

The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).

Stem cell transplant reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. 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.

Conditions

Allogeneic Stell Cell Transplant

Viral Infection

Study ID

NCT04230356

Start date

Jan 27, 2021

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

SCHEDULED ARM:

Inclusion Criteria:

  • Recipient must be at least 21 days after stem cell infusion
  • Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent
  • No critical illness making VST infusion hazardous

Exclusion Criteria:

  • Active acute GVHD grades II-IV.
  • Uncontrolled relapse of malignancy.
  • Infusion of ATG or alemtuzumab within 2 weeks prior to VST infusion. Alemtuzumab levels will be collected in the second week following stem cell infusion in patients who received alemtuzumab as part of their conditioning regimen. The level must be less than or equal to 0.15 prior to infusion of VSTs. In patients with level greater than 0.15, alemtuzumab levels can be checked serially until a level ≤ 0.15 is obtained. They would become eligible for scheduled VST infusion at that point.

TREATMENT ARM

Inclusion Criteria:

  • Blood adenovirus PCR ≥1,000
  • Blood CMV PCR ≥ 500
  • Blood EBV PCR ≥ 9,000
  • Plasma BKV 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.
  • Evidence of invasive CMV infection, defined as pneumonitis, retinitis, colitis, hepatitis
  • 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, defined as hemorrhagic cystitis or BK nephropathy.
  • No active acute GVHD grades II-IV
  • No uncontrolled relapse of malignancy
  • No infusion of ATG or alemtuzumab within 2 weeks of VST infusion.
  • Clinical status must allow tapering of any steroids to < 0.5mg/kg prednisone or other steroid equivalent

Study Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: VSTs to Prevent

VSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection.

experimental: VSTs to Treat

VSTs will be given only if a viral infection develops.

Interventions

Viral Specific T-cells (VSTs) Scheduled

VSTs will be infused into stem cell transplant recipients on schedule.

Viral Specific T-cells (VSTs) Treatment

VSTs will be infused into stem cell transplant recipients only if viremia is detected.

Primary outcome measure

  • Number of Treatment Failures [ Time Frame: 21 - 100 days after transplant ]

Central Contacts and Locations

Central contacts

Jamie Wilhelm, BS

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

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Celeste Dourson, MS

513-636-7679Celeste.Dourson@cchmc.org

Principal Investigator:

Stella Davies, MBBS, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

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.