HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Acute Biphenotypic Leukemia
- Acute Myeloid Leukemia
- Recurrent Childhood Acute Lymphoblastic Leukemia
- Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Undifferentiated Leukemia
- Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Recurrent Acute Undifferentiated Leukemia
- Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
- Recurrent Childhood Acute Myeloid Leukemia
- Chronic Myeloid Leukemia
- Recurrent Acute Lymphoblastic Leukemia
- Refractory Adult Acute Lymphoblastic Leukemia
- Chronic Myelomonocytic Leukemia
- Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
- Juvenile Myelomonocytic Leukemia
- Leukemia
- Minimal Residual Disease
- Recurrent Acute Biphenotypic Leukemia
- Recurrent Acute Myeloid Leukemia
- Recurrent Chronic Myelomonocytic Leukemia
- Refractory Acute Lymphoblastic Leukemia
- Recurrent Mixed Phenotype Acute Leukemia
- Myelodysplastic Syndrome
- Mixed Phenotype Acute Leukemia
- Refractory Myelodysplastic Syndrome
- Recurrent Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 75 years
- Gender
- Both males and females
Description
OUTLINE: This is a dose-escalation study of CD4+ and CD8+ HA-1 TCR T cells. Patients receive fludarabine for 1-3 doses 3-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells intravenously (IV) over 1 hour. After completion of study treatment, patients...
OUTLINE: This is a dose-escalation study of CD4+ and CD8+ HA-1 TCR T cells. Patients receive fludarabine for 1-3 doses 3-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells intravenously (IV) over 1 hour. 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.
Tracking Information
- NCT #
- NCT03326921
- Collaborators
- Alex's Lemonade Stand Foundation
- National Cancer Institute (NCI)
- The Leukemia and Lymphoma Society
- HighPass Bio, Inc.
- Investigators
- Principal Investigator: Elizabeth Krakow Fred Hutch/University of Washington Cancer Consortium
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