Actively Recruiting
Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus or Adenovirus) to Treat Virus Reactivation or Disease After Solid Organ or Hematopoietic Stem Cell Transplantation
Led by Sumithira Vasu · Updated on 2026-04-15
20
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of using donor-derived virus-specific cytotoxic T lymphocytes (CTLs) to treat cytomegalovirus (CMV) or adenovirus (AdV) infections or reactivations in patients who have received either a solid organ transplant or a hematopoietic stem cell transplant. This early phase 1 trial aims to understand how well these specialized immune cells work against viral infections that persist despite standard treatments, providing a potential new approach for transplant recipients facing these complications. Participants are assigned to one of two groups based on their viral infection. One group receives allogeneic CMV-specific CTLs, and the other receives allogeneic AdV-specific CTLs, both given intravenously. If an infection persists after the initial infusion, a second dose may be administered after 28 days. Throughout the study, samples including blood, urine, saliva, cerebrospinal fluid, and lung fluid are collected for monitoring. After treatment, participants are followed for one year to assess outcomes. During the trial, participants undergo regular evaluations to monitor side effects, viral load responses, and the persistence of infused CTLs. Researchers track adverse events up to 30 days post-infusion and follow feasibility measures, including donor availability and T cell dose success, for up to one year. Secondary assessments include survival, risks of graft-versus-host disease, infection rates, and clinical responses to treatment. The total involvement includes treatment infusions and a one-year follow-up period to gather comprehensive safety and effectiveness data.
CONDITIONS
Brief Title
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a solid organ transplant or have received an allogeneic hematopoietic stem cell transplant.
- Cohort A (CMV): Must have documented CMV disease or reactivation with viremia > 500 IU/ml, high risk of antiviral failure, or inability to tolerate antiviral drugs due to toxicity.
- Cohort B (AdV): Must have documented AdV infection or reactivation with symptomatic viral load, symptoms in affected compartments, worsening symptoms despite antiviral therapy, or inability to tolerate antiviral drugs.
- Karnofsky score > 70 (age > 16) or Lansky score > 70 (age < 16).
- Available seropositive haploidentical or matched donor without infection.
- Negative pregnancy test if applicable.
- Written informed consent or assent.
- Donor must be HLA-haploidentical or full match and seropositive for CMV (Cohort A) or AdV (Cohort B).
- Donors must be 18 years or older and meet institutional eligibility standards.
You will not qualify if you...
- Receipt of anti-thymocyte globulin, alemtuzumab, or other T-cell depleting agents within 21 days prior to enrollment.
- Use of prednisone or steroid equivalent > 0.5 mg/kg/day at enrollment (except stable graft-versus-host disease on stable doses).
- Uncontrolled bacterial or fungal infections not adequately treated.
- Hemodynamic instability due to bacterial sepsis or worsening infection symptoms.
- Receipt of donor lymphocyte infusion within 28 days.
- Active acute graft-versus-host disease grades II-IV requiring high-dose steroids or T-cell depleting immunosuppression.
- Acute graft rejection in solid organ transplant requiring augmented immunosuppression.
- Active and uncontrolled relapse of malignancy.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 1 year
Participants receive allogeneic cytomegalovirus-specific or adenovirus-specific cytotoxic T lymphocytes intravenously. Participants with persistent infection may receive a second infusion after 28 days.
Initial infusion visit with possible second infusion after 28 days
Duration - Up to 1 year
Participants are followed for safety, viral response, and clinical outcomes after completion of treatment.
Regular follow-up visits for up to 1 year
Trial Site Locations
Total: 2 locations
1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Suspended
Research Team
T
The Ohio State University Comprehensive Cancer Center
N
Nicole Szuminski
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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