HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Public ClinicalTrials.gov record NCT03326921. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03326921
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
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
- CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR Biological
- Bone Marrow Aspiration Procedure
- Biospecimen Collection Procedure
Biological · Procedure
Eligibility (public fields only)
- Age range
- Up to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 22, 2018
- Primary completion
- Oct 15, 2027
- Completion
- Jul 15, 2028
- Last update posted
- May 17, 2026
2018 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03326921, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 17, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03326921 live on ClinicalTrials.gov.