Actively Recruiting
Antigen Specific Adoptive T Cell Therapy for Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation
Led by Mari Dallas · Updated on 2026-06-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a cell-based immunotherapy called adoptive T cell therapy to treat adenovirus infections in patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT). This experimental therapy aims to help the patient's immune system fight the infection by using virus-specific T cells derived from a donor. The study also focuses on understanding the side effects and toxicities related to this therapy. The treatment involves selecting virus-specific T cells from a donor's blood using the CliniMACS® Prodigy System. Donors who show an immune response to adenovirus undergo leukapheresis to collect cells, which are then processed and infused into the patient as a bolus on day 0. Patients receive a targeted dose based on their weight. Enrollment is staggered with safety observation periods between patients and cohorts to monitor treatment effects. Participants will be closely monitored for safety and effectiveness, including measuring adverse events up to 100 days after infusion and tracking viral and clinical responses within 30 days. The study includes assessments related to treatment timing and cell processing duration. Safety monitoring occurs after specific patient milestones. Total involvement depends on treatment and observation schedules, with detailed follow-up and data collection to evaluate treatment feasibility and outcomes.
CONDITIONS
Brief Title
Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have received allogeneic HSCT and be more than 30 days post-transplant at registration
- Documented adenovirus infection or reactivation, either symptomatic with any viral load or asymptomatic with viral load >1000 copies/ml in blood or qualitative detection in other specimens
- Poor response or contraindication to antiviral therapy such as ganciclovir, valganciclovir, foscarnet, or cidofovir
- Performance score of ECOG 3 or less, Karnofsky score 50 or greater (if 16 years or older), or Lansky score 50 or greater (if under 16 years)
- Women of child-bearing potential and men must agree to use effective contraception from 4 weeks before study entry until 3 months after treatment
- Ability to understand and willingness to sign informed consent or assent if age 14 or older
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with opportunistic viral infections other than adenovirus
- Active grade II-IV acute graft versus host disease or chronic GVHD requiring high-dose steroids (>0.5 mg/kg/day prednisone or equivalent)
- Treatment with antithymocyte globulin within 28 days before planned T cell infusion
- Treatment with virus-specific T cells within 6 weeks before planned infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an infusion of virus-specific, antigen selected T cells to treat adenovirus infection after hematopoietic stem cell transplantation.
1 baseline visit and multiple safety monitoring visits up to 30 days after infusion
Duration - Up to 100 days after infusion
Participants are observed for safety and clinical response after the T cell infusion, including monitoring for adverse events and viral response.
Scheduled visits for safety monitoring and clinical assessments up to 100 days post-infusion
Trial Site Locations
Total: 1 location
1
University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
M
Mari H Dallas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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