Ignite Creation Date:
2024-05-06 @ 10:41 AM
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
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 |