This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.
Additional locations may be listed on ClinicalTrials.gov for NCT03326921.
Locations matching your search criteria
United States
Washington
Seattle
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumStatus: Active
Contact: Elizabeth Krakow
Phone: 206-667-3410
PRIMARY OBJECTIVE:
I. To evaluate the feasibility and safety of HA-1 T TCR T cell immunotherapy in up to 24 people with recurrent acute leukemia after allogeneic hematopoietic stem cell transplantation (HCT).
SECONDARY OBJECTIVES:
I. To determine the in vivo persistence of transferred HA-1 TCR T cells in peripheral blood.
II. To determine the ability of HA-1 TCR T cells to migrate to bone marrow.
III. To evaluate the function of HA-1 TCR T cells before and, if possible, after adoptive T cell transfer.
IV. To observe whether infusion of HA-1 TCR T cells is followed by a reduction of leukemia burden.
V. To observe whether infusion of HA-1 TCR T cells is followed by a reduction of recipient hematopoietic chimerism.
VI. To observe whether infusion of HA-1 TCR T cells is followed by the appearance or recurrence of signs or symptoms of graft-versus-host disease (GVHD).
VII. To determine the recommended phase 2 dose (RP2D) of HA-1 TCR T cells for first infusion.
TERTIARY (EXPLORATORY) OBJECTIVES:
I. To determine the in vivo persistence of transferred HA-1 TCR T cells in peripheral blood and marrow after subsequent infusions of HA-1 TCR T cells.
II. To evaluate the function of HA-1 TCR T cells before and after subsequent infusions of HA-1 TCR T cells.
III. To explore whether subsequent infusions of HA-1 TCR T cells are followed by a reduction of leukemic burden.
IV. To determine whether subsequent infusions of HA-1 TCR cells engender dose-limiting toxicities not observed with prior infusions at the same or lesser doses.
OUTLINE: This is a dose-escalation study of CD4+ and CD8+ HA-1 TCR T cells.
Patients receive chemotherapy on days -7 or -6 to -2 prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells intravenously (IV) over 1 hour. Patients undergo echocardiography during screening and chest x-ray, bone marrow aspiration, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up closely for 12 weeks and then every 6 months for years 1-5, and every year for years 6-15.
Lead OrganizationFred Hutch/University of Washington/Seattle Children's Cancer Consortium
Principal InvestigatorElizabeth Krakow