Phase 1 Study of CIML NK Cell Infusion with IL-2 for Treating Relapsed Myeloid Diseases After Stem Cell Transplantation in Adults and Children 12 Years and Older

What this Trial Is About

Researchers are evaluating cytokine induced memory-like natural killer CIML NK cells combined with IL-2 in patients aged 12 years and older who have Acute Myeloid Leukemia AML, Myelodysplastic Syndromes MDS, Myeloproliferative Neoplasms MPN, or Juvenile Myelomonocytic Leukemia JMML that returned after stem cell transplantation. This Phase I clinical trial aims to test the safety and find the appropriate dose for this investigational treatment, which has not been approved by the FDA for relapsed disease. Participants receive intravenous infusions of CIML NK cells on day 0. Before this, patients are given chemotherapy drugs fludarabine daily for three doses starting on day -5 and cyclophosphamide on days -5 and -4 to prepare the body. The study includes both adult and pediatric patients who have relapsed after haploidentical or HLA-matched stem cell transplants. The treatment is followed for safety and response over several weeks. During the study, participants will be monitored closely for safety for six weeks and assessed for treatment response after 28 days. Further follow-ups include checking for leukemia-free survival and overall survival at 100 days and one year, as well as monitoring for acute and chronic graft-versus-host disease over several months to one year. The trial involves regular evaluations including bone marrow tests, blood tests, and clinical assessments to track disease status and side effects throughout participation.

A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation