Actively Recruiting
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
Led by Sumithira Vasu · Updated on 2026-04-15
20
Participants Needed
2
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial studies the side effects and how well allogeneic cytomegalovirus-specific cytotoxic T lymphocytes (donor cytomegalovirus \[CMV\] specific cytotoxic T-lymphocytes \[CTLs\]) or allogeneic adenovirus-specific cytotoxic T lymphocytes (donor adenovirus-specific \[AdV\] specific CTLs) work in treating CMV or AdV reactivation or infection in participants who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill cancer cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
CONDITIONS
Official 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 had a solid organ transplant or allogeneic hematopoietic stem cell transplant.
- Cohort A: Documented CMV disease or reactivation requiring treatment or high risk of antiviral failure.
- Cohort B: Documented AdV infection or reactivation with symptoms or high viral load.
- Karnofsky performance score over 70 (age > 16) or Lansky score over 70 (age < 16).
- Available seropositive haploidentical or matched donor without infection.
- Negative pregnancy test for female patients of childbearing potential.
- Written informed consent or assent obtained.
- Donor must be HLA-haploidentical or full match and seropositive for CMV (Cohort A) or AdV (Cohort B).
- Donor age 18 or over.
- Donor meets eligibility or suitability standards per institution and FACT guidelines.
You will not qualify if you...
- Receipt of anti-thymocyte globulin, alemtuzumab, or other T-cell depleting agents within 21 days before screening.
- Use of prednisone or steroid equivalent over 0.5 mg/kg/day at enrollment (stable GVHD allowed at or below this dose).
- Uncontrolled bacterial or fungal infections without signs of improvement.
- Hemodynamic instability due to infection or worsening symptoms from bacterial or fungal infections.
- 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 needing augmented immunosuppression.
- Active, uncontrolled relapse of malignancy.
AI-Screening
AI-Powered Screening
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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
CONTACT
N
Nicole Szuminski
CONTACT
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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