Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem… (NCT03475212) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
United States52 participantsStarted 2018-06-20
Plain-language summary
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.
Who can participate
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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.
For EBV infection, standard therapy is defined as rituximab given at 375 mg/m2 in patients for 1-4 doses with a CD20+ tumor.
Additional Inclusion Criteria:
* Patients with simultaneous infe…
What they're measuring
1
Feasibility to identify suitable HLA matched VST products
Timeframe: 30 days
2
Incidence of Treatment-Emergent Adverse Events
Timeframe: 30 days
3
Efficacy of VST at 30 days as measured by viral load