This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.
Aged 6 months to 80 years.
Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant.
Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease.
Karnofsky/Lansky score of ≥ 50.
Patients with uncontrolled infections.
Current evidence of GVHD > grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
Pregnancy (female of childbearing potential).
Patients with high risk AML and MDS who have received an allo-HSCT and have not had hematologic relapse of disease.
Catherine Bollard
Lead sponsor
Children's National Research Institute
Sponsor institution
Children's National Research Institute
Collaborator
Johns Hopkins University
Collaborator