Phase I-II Study of Donor-Derived Cord Blood T Cell Immunotherapy for Viral Infections After Transplant Dose Finding for Treatment or Prevention of EBV, CMV, BKV, and Adenovirus Reactivation

What this Trial Is About

This trial involves patients at risk for viral infections such as CMV, EBV, BKV, and adenovirus, particularly after umbilical cord blood transplantation. It aims to find the best dose of donor-derived cytotoxic T lymphocytes CTLs specific to these viruses using a Phase I-II dose-finding design. The trial uses a method called EffTox to decide on dose levels for intravenous CTL infusions and evaluates toxicity and efficacy to identify the optimal dose. Participants receive intravenous CTL infusions at one of three dose levels 1x107, 2x107, or 5x107 cells per square meter of body surface area. The CTLs are thawed and injected slowly over 1-2 minutes, starting from day 30 after transplant. The trial treats patients in cohorts of two, observing each for 45 days before deciding on dose escalation. Additional doses may be given 28 days after the first infusion in some cases, especially if partial response or other therapies affect CTL function. Throughout the study, participants are monitored closely for adverse effects related to the infusion during a 45-day toxicity follow-up. Researchers assess the presence of infused CTLs over 12 months to evaluate their impact. Patients undergo regular clinical observations to watch for toxicity, graft-versus-host disease, and viral reactivation. Total participation duration varies depending on dosing and follow-up schedules, with safety and efficacy being key outcome measures.

Adoptive Cord Blood Immunotherapy for EBV, CMV, BKV and Adenovirus Reactivation/Infection or Prophylaxis