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RECRUITING Phase 1

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

NCT03326921 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • BIOLOGICAL CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR

Study Locations (1)

Washington

  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2018-02-23
Est. Completion 2028-07-16
Phase Phase 1

Sponsor

Fred Hutchinson Cancer Center

319 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03326921

The ClinicalTrials.gov registry entry for NCT03326921 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Refractory Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03326921 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03326921 about?

NCT03326921 is a clinical study titled "HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant". 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 rece...

What is the current status of trial NCT03326921?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2018-02-23. Estimated completion is 2028-07-16.

What conditions does trial NCT03326921 study?

This clinical trial studies the following conditions: Refractory Acute Lymphoblastic Leukemia, Recurrent Myelodysplastic Syndrome, Juvenile Myelomonocytic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03326921?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03326921?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03326921 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial