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ACES


Title Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES)
Therapeutic Area Bone Marrow Transplantation
Principal Investigator Dr. Jason Law
Min Age 0 Years
Gender All
Contact Kristen Baker
617-636-7406
More Information https://www.clinicaltrials.gov/ct2/show/NCT03475212

Overview

The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.

Study Details

Inclusion Criteria

  • Patients who have received any type of allogeneic transplant or who have a primary immunodeficiency disorder will be eligible if they have CMV, adenovirus, and/or EBV infection/disease with failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy.
  • Patients must meet one of the following criteria:
    • Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cell or single or double cord blood within the previous 18 months, OR
    • Have a diagnosed primary immunodeficiency disorder (as defined by clinical and laboratory evaluations) and not undergone HSCT.
  • Treatment of the following persistent or relapsed infections despite standard therapy:
    • CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir for at least 14 days.
    • Adenovirus: Treatment of persistent or relapsed adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or brincidofovir.
    • EBV: Treatment of persistent or relapsed EBV infection despite standard therapy.

 

Exclusion Criteria

  • Patients receiving ATG, Campath, Basiliximab or other immunosuppressive monoclonal antibodies targeting T-cells within 28 days of screening for enrollment.
  • Patients who have received donor lymphocyte infusion (DLI) or other experimental cellular therapies within 28 days.
  • Current therapy with ruxolitinib or other JAK inhibitors within the previous 3 days.

Study Requirements

Study participation will last 12 months. Prior to receiving a VST infusion, a physical exam, blood test (2 tsp), urine pregnancy test and another 1-4 tsp of blood will be collected.

Virus-specific T cells will be drawn from a separate donor, assessed to ensure correct HLA typing, and given to the subject through their pre-existing central line.

Physical exams will be done weekly after the first 30 days, then at 6 weeks, 3 months, and 12 months.

Blood tests will also be done at these vists to test the viral load and for other types of infection.