Third Party Viral Specific T-cells (VSTs)

PHASE2RecruitingINTERVENTIONAL
Enrollment

750

Participants

Timeline

Start Date

September 2, 2015

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Viral InfectionViral ReactivationInfection in an Immunocompromised Host
Interventions
BIOLOGICAL

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"

Trial Locations (4)

43210

RECRUITING

The Ohio State University Wexner Medical Center - James Cancer Hospital, Columbus

44308

RECRUITING

Akron Children's Hospital, Akron

45219

COMPLETED

University of Cincinnati Medical Center, Cincinnati

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
lead

Children's Hospital Medical Center, Cincinnati

OTHER