Pilot Study of Haploidentical or Matched Donor Virus-Specific T-cells (Cytomegalovirus (CMV) or Adenovirus (AdV)) to Treat CMV or AdV Reactivation or Disease in Patients After Solid Organ or Hematopoietic Stem Cell Transplantation (HCT)
Sumithira Vasu
Summary
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.
Description
PRIMARY OBJECTIVE I. Assess the safety and feasibility of administering virus specific-CTLs from haploidentical donors in transplant patients both solid organ transplantation (SOT) and hematopoietic cell transplantation (HCT) with CMV/AdV infection despite standard therapy. 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 aden…
Eligibility
- Age range
- 1–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Patients must have solid organ transplant or have received allogeneic hematopoietic stem cell transplant. * • Cohort A (CMV): Must have documented CMV disease or reactivation, as by: * Viremia as detected by quantitative polymerase chain reaction (PCR) (\> 500 IU/ml) in the peripheral blood requiring treatment OR * High risk for antiviral failure due to history of recurrent CMV reactivations or evidence of antiviral drug resistance, OR * Unable to tolerate antiviral drugs due to renal toxicity, bone marrow suppression, transfusion dependent anemia and thrombocytop…
Interventions
- BiologicalAllogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes
Given intravenously
- BiologicalAllogeneic Adenovirus-specific Cytotoxic T Lymphocytes
Given intravenously
Locations (2)
- Nationwide Children's HospitalColumbus, Ohio
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio