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NCT03326921 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Myelodysplastic Syndrome, sponsored by Fred Hutchinson Cancer Center.

Recruiting
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT03326921: Recruiting Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Myelodysplastic Syndrome, sponsored by Fred Hutchinson Cancer Center.

NCT03326921 is a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Myelodysplastic Syndrome that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 24 participants, below the 44-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03326921, a Phase 1 study of Refractory Acute Lymphoblastic Leukemia and Recurrent Myelodysplastic Syndrome, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.

RECRUITING
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

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.

Primary Outcome

Proportion of subjects for whom a HA-1 TCR T cell product can be produced.

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
Fred Hutchinson Cancer Center

483 total trials

What NCT03326921 shows while recruiting

NCT03326921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 44-participant average among 21 other Refractory Acute Lymphoblastic Leukemia trials with a reported enrollment target (45% lower).

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.

NCT03326921 reports a single indexed study location in Washington.

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.

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).

Who is sponsoring clinical trial NCT03326921?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Refractory Acute Lymphoblastic Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03326921's enrollment target sits among peer trials

24 15th of 21 higher than 5 of 21 other Refractory Acute Lymphoblastic Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Refractory Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03326921, the US trial registry maintained by the National Library of Medicine. NCT03326921 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.