Third Party Viral Specific T-cells (VSTs)

Part of paid clinical trials in Akron, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT02532452
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Infection in an Immunocompromised Host
  • Viral Infection
  • Viral Reactivation

Eligibility Criteria

Sex
ALL
Age
2 Days - N/A
Healthy Volunteers
Not accepted

Interventions

  • Viral Specific VST Infusion — BIOLOGICAL
    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

Study Details

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.

Key Dates

Start date
Sep 2, 2015
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Viral Specific VST Infusion
    3rd party VST infusion

Primary Outcome Measure

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

Central Contacts

Locations (4)

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-
The Ohio State University Wexner Medical Center - James Cancer HospitalColumbusOhio43210
Nicole Szuminski, MS, RN, CCRC
[email protected]
Polina Shindiapina, MD, PhD (PRINCIPAL_INVESTIGATOR)

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, OHThe Ohio State University Wexner Medical Center - James Cancer Hospital· Columbus, OH

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