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New treatment option for Allogeneic Hematopoietic Stem Cell Transplantation
Official title Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation
ClinicalTrials.gov ID: NCT03378102
What this study is testing
What is IFN-gamma-secreting HAdV antigen specific T cells?
IFN-gamma-secreting HAdV antigen specific T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for allogeneic hematopoietic stem cell transplantation.
Also referred to as Antigen-selected, adenovirus-specific T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 and older
You may be able to join if
- Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.
- Patients must have evidence of documented HAdV infection/reactivation. Patients may be:
- Symptomatic with any detectable viral load OR
- Asymptomatic with viral load that is: \>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens
- Patients must have poor response and/or contraindication to therapy:
You likely can't join if
- Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants...
- Patients with opportunistic viral infections other than HAdV.
- Patients with active, grade II-IV, acute graft versus host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid...
- Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
- Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
See the full eligibility criteria
- Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.
- Patients must have evidence of documented HAdV infection/reactivation. Patients may be:
- Symptomatic with any detectable viral load OR
- Asymptomatic with viral load that is: \>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens
- Patients must have poor response and/or contraindication to therapy:
- Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR
- New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR
- Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet.
- Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 50
- The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier...
- people who are 14 years and older must have the ability to understand and the willingness to sign a written informed consent document, or assent document.
- Pregnant or breastfeeding women are excluded from this study. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above...
- Patients with opportunistic viral infections other than HAdV.
- Patients with active, grade II-IV, acute graft versus host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\>0.5 mg/kg/day prednisone or its equivalent) as treatment.
- Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
- Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 months and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.