Phase 2 Study of Donor-Derived BK-Specific Cytotoxic T Lymphocytes for Treating Patients With Malignancies, HIVAIDS, or Transplants Infected With BK or JC Virus

What this Trial Is About

Researchers are evaluating the use of donor cytotoxic T lymphocytes CTLs to treat patients who have malignancies associated with BK andor JC virus infections. These CTLs are specially grown from donated blood cells to target viruses that often cause infections in transplant patients. The study aims to assess the effectiveness, feasibility, and safety of these BK-specific CTLs administered to patients with various malignancies, HIVAIDS, or a history of solid organ transplant who have BK and JC infections. Participants will receive allogeneic BK-specific cytotoxic T-lymphocytes through an intravenous infusion lasting about 30 minutes. Those showing partial response, stable disease, or progression may receive up to 19 additional CTL infusions at least two weeks apart if they remain eligible. After completing the CTL treatments, participants will be followed for up to 12 months to monitor health and treatment effects. During the study, participants will undergo regular assessments including response evaluation within 56 days, monitoring for graft-versus-host disease within 28 days after the last infusion, and adverse event tracking up to 100 days. Additional measures include overall survival and kidney function tests monitored up to 12 months after treatment. The study includes laboratory biomarker analyses to support correlative research and involves periodic follow-up visits to track participants health and treatment outcomes.

Cytotoxic T Lymphocytes in Treating Patients With Malignancies With BK and/or JC Virus