This phase I 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 patients who have undergone stem cell transplant or solid organ transplant. White blood cells from donors may be able to kill viral cells in patients with cytomegalovirus or adenovirus that has come back after a stem cell or solid organ transplant.
Additional locations may be listed on ClinicalTrials.gov for NCT03665675.
Locations matching your search criteria
United States
Ohio
Columbus
Nationwide Children's HospitalStatus: Temporarily closed to accrual
Contact: Christopher P Ouellette
Phone: 614-722-4452
Ohio State University Comprehensive Cancer CenterStatus: Temporarily closed to accrual
Contact: Sumithira Vasu
Phone: 614-293-3196
PRIMARY OBJECTIVE
I. Assess the safety and feasibility of administering virus specific-CTLs from haploidentical donors to both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV/AdV viremia or disease.
OUTLINE:Patients are assigned to 1 of 2 Cohorts.
COHORT A: Patients receive allogeneic cytomegalovirus-specific cytotoxic T lymphocytes intravenously (IV). Patients undergo blood, urine, saliva, cerebrospinal fluid (CSF), and bronchoalveolar fluid sample collection on the trial.
COHORT B: Patients receive allogeneic adenovirus-specific cytotoxic T Lymphocytes IV. Patients undergo blood, urine, saliva, CSF, and bronchoalveolar fluid sample collection on the trial.
After completion of study treatment, participants are followed up at 1 year.
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSumithira Vasu