Donor-Derived Viral Specific T-cells (VSTs)

Part of paid clinical trials in Akron, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT02048332
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Allogeneic Stem Cell Transplant
  • Viral Infection
  • Viral Reactivation

Eligibility Criteria

Sex
ALL
Age
4 Weeks - N/A
Healthy Volunteers
Not accepted

Interventions

  • Viral specific VST Infusion — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Feb 5, 2014
Status verified
Dec 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
750 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Viral Specific VST Infusion
    Viral reactivation or infection. VST Reinfusion required.

Primary Outcome Measure

Successful production of viral specific T-cells [ Time Frame: Within 30 days post culture initiation ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Akron Children's HospitalAkronOhio44308
Courtney Culbertson, CNP
[email protected]
330-543-3338
Megan Sampson, MD (PRINCIPAL_INVESTIGATOR)
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Jamie Wilhelm
[email protected]
513-803-1102
Michael Grimley, MD (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Medical CenterCincinnatiOhio45219-

Find similar trials in Akron, OH

By research site
Akron Children's Hospital· Akron, OHCincinnati Children's Hospital Medical Center· Cincinnati, OHUniversity of Cincinnati Medical Center· Cincinnati, OH

Related Studies