drugset / Trial / NCT06011486

Expansion of Virus-Specific Lymphocytes for Cell Therapy

NCT06011486 ↗

Phase 1 Recruiting 10 enrolled Hospital Israelita Albert Einstein
NaSingle-groupOpen-labelTreatment

Summary

Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation. In this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private. This project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity / mortality after transplantation, as well as a reduction in the hospitalization period.

Timeline

Start
2024-06-10
Primary completion
2025-06-10
Completion
2026-06-10

Drugs

EvaluationDrugModalityDoseRoute
Subject ImmuneCellVir-I Unknown 10000 cells/kg Intravenous
Subject ImmuneCellVir-I Unknown 20000 cells/kg Intravenous
Subject ImmuneCellVir-I Unknown 1e+06 cells Intravenous