Open-Label Pilot Study of Haploidentical Donor Adenovirus Specific T Lymphocytes (ADV-VSTS) for the Treatment of Refractory Adenovirus Infection and/or Disease in Hospitalized Patients
Nationwide Children's Hospital
Summary
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
Eligibility
- Age range
- Up to 60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 0 days to 60 years with one of the following conditions: 1. Patients who are solid organ transplantation recipients (renal, heart, lung, liver, pancreas, small bowel, multi-visceral) and are \> 28 days post-transplant at the time of screening. 2. Patients with underlying malignancy who are receiving or have received chemotherapy within 6 months of screening. 3. Patients with known autoimmune or autoinflammatory conditions, not associated with a known underlying primary immunodeficiency 4. Patients who are receiving or have received systemic immunosuppressive…
Interventions
- BiologicalAdenovirus Specific T lymphocytes
ADV-VSTs is being proposed for the treatment of refractory ADV infection and/or disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation/IFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs.
Location
- Nationwide Children's HospitalColumbus, Ohio