Study of Viral Specific T-Lymphocytes to Treat Adenovirus, Cytomegalovirus, or Epstein-Barr Virus Infections in Patients After Stem Cell or Organ Transplant or With Weakened Immunity

What this Trial Is About

Researchers are evaluating the use of partially matched viral specific T cells to treat infections caused by adenovirus, cytomegalovirus CMV, and Epstein-Barr virus EBV in patients who have weakened immune systems due to prior allogeneic hematopoietic cell transplant, solid organ transplant, or other causes. This phase III study aims to assess whether these donor-derived T cells can help control persistent or resistant viral infections that have not responded to standard therapies. The study uses a new gamma capture technology to generate these virus-specific T cells more quickly and potentially at lower cost than patient-specific products. The treatment involves collecting peripheral blood mononuclear cells from a donor, stimulating them with viral-specific antigens, and then isolating the viral specific T cells using an interferon gamma cytokine capture system. Patients may receive up to five infusions of these cells from one or two donors, spaced at least 14 days apart, especially if they show a partial or no response to initial infusion. This cellular therapy is given intravenously, and patients are monitored closely for safety and effectiveness. Participants undergo viral load testing through various methods including PCR and respiratory panels at baseline and multiple time points up to six months after the first infusion. They will be followed for six months post-infusion, with additional safety monitoring for graft-versus-host disease and adverse events if they receive more than one infusion. Medical records may be reviewed for up to one year after the last infusion to collect further data. The main outcomes measured include severe graft-versus-host disease and serious adverse events within the first 30 to 90 days after treatment.

Viral Specific T-Lymphocytes to Treat Infection With Adenovirus, Cytomegalovirus or Epstein-Barr Virus in Patients With Compromised Immunity