Phase 1 Study of Virus-Specific Lymphocyte Therapy for CMV Infection in Adults After Bone Marrow Transplant

What this Trial Is About

This research aims to evaluate the safety and tolerability of cytomegalovirus CMV-specific lymphocyte infusion therapy in patients who have undergone allogeneic bone marrow transplantation and experience CMV infections that do not respond to conventional treatments or where standard therapies may be toxic. The study focuses on treating CMV infections that can cause severe complications such as neurological, pulmonary, gastrointestinal, and eye problems, leading to serious illness and extended hospital stays. It explores a new cell-based therapy that may help reduce these complications and improve patient outcomes after transplantation. The treatment involves preparing CMV-specific T lymphocytes from platelet donor blood, selecting cells that respond to CMV peptides using interferon gamma capture, and freezing them for infusion. Patients will receive an intravenous infusion of these cells, with a dose of 1x106 CMV-specific T cells about 1-2x104 cells per kilogram of body weight. The infusion can be repeated up to two times, spaced at least two weeks apart, if patients continue to meet the study criteria. This phase I, single-arm study follows strict safety and quality protocols for cell selection, testing, and administration. Participants will be closely monitored for infusion reactions and signs of graft versus host disease GvHD through vital signs checks during and after infusion, with follow-up visits weekly for seven weeks and additional visits at 100 days, six months, and one year post-infusion. Blood tests will assess liver and kidney function, blood counts, and immunogenicity by measuring anti-HLA antibodies. Researchers will also evaluate antiviral activity by measuring CMV viral load, clinical symptom scores, and immune response levels. Additional exams like CT scans, colonoscopy, eye exams, or biopsies may be done if needed, and cell biodistribution will be assessed. The total study duration includes long-term safety and effectiveness follow-up up to one year after treatment.

Expansion of Virus-Specific Lymphocytes for Cell Therapy