Actively Recruiting
Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection After Stem Cell Transplant
Led by Mari Dallas · Updated on 2025-10-22
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility of a cell-based immunotherapy using donor T-cells that specifically target cytomegalovirus (CMV) infections occurring after hematopoietic stem cell transplant (HSCT). This investigational approach, called adoptive T-cell therapy, aims to help the immune system fight CMV by infusing virus-specific T-cells selected with the CliniMACS Prodigy System. The study also seeks to describe the safety and potential toxicities of this therapy as well as its ability to eradicate CMV infections. Participants will receive a one-time infusion of CMV-specific adoptive T-cells, with the expected dose ranging from 10^3 to 10^5 selected T-cells per kilogram of recipient weight. After the infusion, patients will be observed for 4 weeks to assess treatment effects and safety. This study includes a single treatment group and focuses on early-phase evaluation of this experimental biological therapy. During the study, participants will be monitored for adverse events up to 100 days after transplant, along with assessments of CMV infection eradication and response rates. Researchers will collect data on safety and treatment outcomes during follow-up. Participants will undergo evaluations including clinical assessments and laboratory monitoring to track immune response and infection status throughout the study period.
CONDITIONS
Brief Title
T Cell Therapy of Opportunistic Cytomegalovirus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
- Patients must have documented opportunistic CMV infection or reactivation with either asymptomatic viremia (>1000 copies/ml) or symptoms related to CMV infection
- Patients must meet one of the following: no improvement in viral load after 14 days of antiviral therapy, new or worsening CMV-related symptoms on antiviral therapy, contraindications or adverse effects to antiviral therapy, or second recurrence of CMV infection
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Women of child-bearing potential and men must agree to use adequate contraception during and for 3 months after study participation
- Ability to understand and willingness to sign informed consent or assent document
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients with opportunistic viral infections other than CMV
- Patients with active grade 2 to 4 acute graft versus host disease (GVHD), 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 before planned infusion
- Donor must be at least partially HLA compatible and seropositive for CMV
- Donor must meet criteria for leukapheresis or whole blood donation at the transplant center
- Donor must be at least 18 years old and meet selection criteria of the stem cell transplant program
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.
Duration - Single infusion with follow-up for 4 weeks
Participants receive a one-time infusion of CMV specific adoptive T-cells to treat opportunistic CMV infection after stem cell transplant.
1 infusion visit and follow-up visits over 4 weeks
Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
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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