Actively Recruiting
Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation
Led by Mari Dallas · Updated on 2025-03-12
20
Participants Needed
1
Research Sites
517 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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
- Patients must have documented adenovirus infection or reactivation, either symptomatic with any detectable viral load or asymptomatic with viral load >1000 copies/ml in blood or positive in stool, urine, or other specimens
- Patients must have poor response or contraindication to antiviral therapy, such as no viral load improvement after at least 14 days of treatment, worsening symptoms, or adverse effects from antiviral drugs
- Performance score must be ECOG ≤ 3, Karnofsky (≥16 years) or Lansky (<16 years) ≥ 50
- Women of childbearing potential and men must agree to use effective contraception starting 4 weeks before enrollment through 3 months after treatment
- Participants aged 14 years and older must understand and be willing to sign informed consent or assent
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with opportunistic viral infections other than adenovirus
- Patients with active grade II-IV acute graft versus host disease or chronic GVHD or requiring high doses of glucocorticosteroids (>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 (42 days) before planned infusion
AI-Screening
AI-Powered Screening
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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
CONTACT
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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