Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)
Fred Hutchinson Cancer Center
Summary
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.
Description
OUTLINE: This is a dose-escalation study of CD4+ and CD8+ HA-1 TCR T cells. Patients receive lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide or debulking regimens as specified in the protocol) ending 2-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells intravenously (IV). 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. Initial study activity was funded in part by HighPass Bio, Inc. Current study activity is funded i…
Eligibility
- Age range
- Up to 80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject age 0-80 years at the time of enrollment. * Subject must express HLA-A\*0201 * Subject must have the HA-1(H) genotype (RS\_1801284: A/G, A/A) * Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either: * HLA-A\*0201 positive and HA-1(H) negative (RS\_1801284: G/G) or * HLA-A\*0201 negative * Subjects who are currently undergoing or who previously underwent allogeneic HCT for * Acute my…
Interventions
- BiologicalCD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
Given IV
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBiospecimen Collection
Undergo blood sample collection
Location
- Fred Hutch/University of Washington Cancer ConsortiumSeattle, Washington