Phase III Study of Antigen-Specific Cytotoxic T Cell Infusions to Treat Opportunistic Infections in Immunocompromised Patients

What this Trial Is About

Opportunistic infections caused by viruses such as Epstein Barr Virus EBV, Cytomegalovirus CMV, adenovirus AdV, and BK virus BKV pose serious risks for patients undergoing hematopoietic stem cell transplantation HSCT or those who are immunocompromised. These infections often lead to significant illness and death, particularly during the early period after transplant. Traditional antimicrobial drugs are used to prevent and treat these infections, but some patients develop resistance, making treatment challenging. This study evaluates the safety and effectiveness of using microbial-specific cytotoxic T lymphocytes CTLs to treat these infections in such vulnerable patients. In this trial, researchers prepare CTLs from a patients own or a donors blood by activating and enriching T cells with pathogen-specific antigens. The prepared CTLs are infused intravenously at doses ranging from approximately 1x105 to 1x106 cells per kilogram of body weight. Patients may receive repeated CTL infusions to combat microbial infections. The process of preparing the CTLs takes about 12 to 17 days. This phase III trial focuses on evaluating the safety and monitoring the antimicrobial effects of these infused CTLs. Participants will be followed closely after infusion with weekly visits for one month, then monthly for three months, and subsequently every three months until the study concludes. During these visits, doctors will assess safety using standard criteria for adverse events and monitor viral loads to evaluate treatment response. Additional evaluations include immune system recovery, incidence of graft-versus-host disease-like symptoms, and other potential infusion-related effects. The total study duration extends up to the end of 2030, allowing for long-term monitoring of participants health and immune status.

Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections