Viewing Study NCT03326921



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Last Modification Date: 2024-10-26 @ 12:34 PM
Study NCT ID: NCT03326921
Status: SUSPENDED
Last Update Posted: 2024-03-21
First Post: 2017-10-05

Brief Title: HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Sponsor: Fred Hutchinson Cancer Center
Organization: Fred Hutchinson Cancer Center

Study Overview

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
Status: SUSPENDED
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Pause in funding
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
RG9217022 OTHER Fred HutchUniversity of Washington Cancer Consortium None
NCI-2017-01054 REGISTRY None None
9716 OTHER None None