Treatment Using Haploidentical Viral-Specific T-Cells for Cytomegalovirus and Adenovirus Infections After Stem Cell Transplant in Children 18 and Under

What this Trial Is About

Researchers are studying whether T-cells specifically targeting cytomegalovirus CMV and adenovirus ADV, taken from donors using an automated device, can be a safe and effective treatment for patients who have these infections after a stem cell transplant. This Phase 2 trial aims to see if these virus-specific T-cells VSTs can reduce the viral load in patients blood and improve infection outcomes. The study is sponsored by St. Jude Childrens Research Hospital and involves patients up to 18 years old. The study includes two groups Cohort A with donors identical to the stem cell donor, and Cohort B with different haploidentical donors. Donors are screened for the presence of virus-specific T-cells using a specialized flow cytometry test. Donor white blood cells are collected using the Spectra Optia system, and virus-specific T-cells are isolated using the Prodigy device over 24-36 hours. Participants receive a single intravenous infusion of these selected T-cells, with preparation involving the CliniMACS device. Participants will be closely monitored before and after the infusion, including blood tests to measure viral load at 4 weeks, 3 months, and 6 months post-infusion. The primary goal is to see a significant reduction in the virus in the blood at 4 weeks. Safety assessments include tracking adverse events such as infusion reactions, cytokine release syndrome, neurotoxicity, graft-versus-host disease, and other toxicities. The study lasts several months to assess both the effectiveness and safety of this treatment approach.

Haplo-identical Viral-Specific T-cells for Treatment of Cytomegalovirus and Adenovirus Infections After Hematopoietic Cell Transplantation