Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3+
SponsorMari Dallas
About this trial
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. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy.
Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into the patient, to try to give the immune system the ability to fight the infection. Adoptive T cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.
Symptomatic with any detectable viral load OR
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
Disqualifiers
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, breastfeeding should be discontinued if the mother participates in this trial.
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.
Trial design
Design model
Single group
Treatments tested in this trial
IFN-gamma-secreting HAdV antigen specific T cells
Biological/VaccineAntigen selected cells will be obtained using the CliniMACS(R) Prodigy System from a compatible donor. Isolated cells will be infused into the donor to treat human adenoviral infection after transplant
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Interferon (IFN)-gamma-secreting HAdV antigen specific T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients with severe adverse events
This is a measure of feasibility: Severe adverse events are related to the infusion of virus-specific, antigen selected T cells, Grade ≥ 3 acute graft versus host disease,• Death within 30 days of the infusion of the virus-specific, antigen selected T cells that is considered by the investigators to be probably or possibly related to the T cell infusion
Time frame
Up to 100 days after infusionSecondary outcomes
1
Number of patients with viral response
Clearance: No measurable viral load after therapy Response: Decrease by ≥ 1 log after therapy Persistence: Change by \< 1 log after therapy Progression: Increase by ≥1 log after therapy
Time frame
Up to 30 days after infusion2
Number of patients with clinical response
Clinical Response: Resolution of symptoms and signs of viral infection or reactivation Incomplete clinical response: Improvement, but not resolution of symptoms and signs of viral infection or reactivation Stable clinical disease: No change in symptoms or signs of viral infection Progressive clinical disease: Worsening of symptoms or signs of viral infection
Time frame
Up to 30 days after infusion3
Time from enrollment to T cell product infusion
Time frame
Up to 24 hours4
Time from peripheral mononuclear cell collection to T cell product infusion
Time frame
Up to 15 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Mari Dallas
Lead sponsor
Case Comprehensive Cancer Center
Sponsor institution
Source ClinicalTrials.gov