NCT03326921

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 in part by PromiCell Therapeutics, Inc.

Conditions

• Juvenile Myelomonocytic Leukemia
• Recurrent Acute Biphenotypic Leukemia
• Recurrent Acute Undifferentiated Leukemia
• Recurrent Childhood Acute Lymphoblastic Leukemia
• Recurrent Childhood Acute Myeloid Leukemia
• Refractory Acute Lymphoblastic Leukemia
• Refractory Adult Acute Lymphoblastic Leukemia
• Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
• Recurrent Myelodysplastic Syndrome
• Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
• Refractory Myelodysplastic Syndrome
• Acute Undifferentiated Leukemia
• Mixed Phenotype Acute Leukemia
• Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Acute Myeloid Leukemia
• Myelodysplastic Syndrome
• Acute Myeloid Leukemia
• Acute Lymphoblastic Leukemia
• Acute Biphenotypic Leukemia
• Chronic Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Minimal Residual Disease
• Recurrent Chronic Myelomonocytic Leukemia
• Recurrent Mixed Phenotype Acute Leukemia
• Leukemia
• Chronic Myeloid Leukemia, BCR-ABL1 Positive

Interventions

Type	Name	Description
BIOLOGICAL	CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR	Given IV
PROCEDURE	Bone Marrow Aspiration	Undergo bone marrow aspiration
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2018-02-23
• Primary completion: 2027-10-16
• Completion: 2028-07-16
• First posted: 2017-10-31
• Last updated: 2025-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study