RecruitingPhase 1Phase 2NCT02048332

Donor-Derived Viral Specific T-cells (VSTs)

Donor-Derived Viral Specific T-cells (VSTs) for Treatment of Viral Infections After Allogeneic Stem Cell Transplant

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

750 participants

Start Date

Feb 5, 2014

Study Type

INTERVENTIONAL

Conditions

Viral reactivation allogeneic stem cell transplant Viral Infection

Summary

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.

Eligibility

Min Age: 4 Weeks

Inclusion Criteria3

Recipient 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
Recipient must have achieved engraftment with ANC ≥ 500

Exclusion Criteria4

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

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Interventions

BIOLOGICALViral specific VST Infusion

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.