Phase I Study of HA-1 Specific T Cell Receptor Therapy for Children and Adults With Recurrent or Refractory Acute Leukemia After Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the side effects and best dose of CD4 and CD8 HA-1 T cell receptor TCR T cells in treating patients with acute leukemia that persists, returns, or does not respond after a donor stem cell transplant. This phase I trial explores how genetically modified donor T cells can recognize leukemia cells by targeting the HA-1 protein on their surface. The study aims to better understand the feasibility and safety of this adoptive immunotherapy approach for leukemia patients post-transplant. Participants receive lymphodepleting chemotherapy, such as fludarabine and cyclophosphamide, ending 2 to 14 days before receiving the HA-1 TCR T cells intravenously. After T cell infusion, patients are closely followed for 12 weeks, then every 6 months for years 1 through 5, and annually for years 6 through 15. The study involves procedures like bone marrow aspirations and blood sample collections to monitor treatment effects. During the trial, researchers assess the ability to manufacture and administer the HA-1 TCR T cells, monitor dose-limiting toxicities within 12 weeks, and track how long the modified T cells persist in the blood and bone marrow for up to one year. They also evaluate the reduction of leukemia and normal recipient cells in bone marrow and observe any new or recurrent graft-versus-host disease symptoms for one year. Long-term follow-up up to 15 years helps ensure ongoing safety and effectiveness assessments.

HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant