Preventing Cytomegalovirus Infection After Haploidentical Stem Cell Transplant Using Donor-Derived Immune Cell Therapy

What this Trial Is About

Cytomegalovirus CMV infection is a significant cause of illness and death in patients who receive allogeneic hematopoietic stem cell transplants, especially from haploidentical donors HAPLO. This study evaluates the use of donor-derived CMV-specific cytotoxic T lymphocytes CMV-CTLs given as a preventive treatment to reduce CMV infection after HAPLO transplantation. The trial is a Phase 2 clinical study focusing on the safety and effectiveness of this immunotherapy approach in transplant patients. Patients eligible for this study will receive an infusion of donor-derived CMV-CTLs around 21 days plus or minus 7 days after their HAPLO transplant if their donors are CMV-seropositive. The CMV-CTLs are obtained from donor leukapheresis and processed to isolate the specific cells, which are then given intravenously to the patient at a dose of 1x105 cells per kilogram. After the initial infusion, patients will be monitored weekly for CMV DNA levels using quantitative PCR for at least 100 days. If a patient develops a viral infection after the CMV-CTL infusion, they may receive standard anti-CMV antiviral drugs. During the study, participants will undergo weekly blood tests to track CMV viral load for up to 100 days after transplant. The primary outcome is the incidence of CMV infection within 100 days post-infusion. Secondary outcomes include the use of CMV antiviral drugs and occurrence of CMV disease within one year after transplant. Safety and follow-up assessments will continue for up to one year to evaluate the long-term effects of the treatment. Overall participation will involve careful monitoring and regular clinical visits to ensure patient safety and gather study data.

Prophylaxis of Cytomegalovirus Infection With Adoptive Cell Inmunotherapy